Created at Source Raw Value Validated value
Oct. 17, 2022, 10:36 a.m. usa

history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. subjects with cardiovascular disease subjects with diabetes subjects with pulmonary diseases such as copd or asthma history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) clinically significant abnormal electrocardiogram at screening. note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. positive serology results for hiv, hbsag, or hcv antibodies febrile illness with temperature ≥38°c within 7 days of dosing female subject who is pregnant or breastfeeding donated blood within 56 days of enrollment known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure treatment with another investigational drug within 28 days of dosing treatment with a monoclonal antibody within 3 months of enrollment positive serology results for sars-cov-2 antibodies (not applicable for cohort 5). positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements use of h1 antihistamines or beta-blockers within 5 days of dosing use of any prohibited medication within 28 days prior to screening or planned use during the study period note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period note: includes trials that have a study intervention such as a drug, biologic, or device is a study site employee or staff note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit). for cohort 5, subjects who received a covid-19 vaccine within 14 days prior to enrollment are excluded.

history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. subjects with cardiovascular disease subjects with diabetes subjects with pulmonary diseases such as copd or asthma history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) clinically significant abnormal electrocardiogram at screening. note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. positive serology results for hiv, hbsag, or hcv antibodies febrile illness with temperature ≥38°c within 7 days of dosing female subject who is pregnant or breastfeeding donated blood within 56 days of enrollment known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure treatment with another investigational drug within 28 days of dosing treatment with a monoclonal antibody within 3 months of enrollment positive serology results for sars-cov-2 antibodies (not applicable for cohort 5). positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements use of h1 antihistamines or beta-blockers within 5 days of dosing use of any prohibited medication within 28 days prior to screening or planned use during the study period note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period note: includes trials that have a study intervention such as a drug, biologic, or device is a study site employee or staff note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit). for cohort 5, subjects who received a covid-19 vaccine within 14 days prior to enrollment are excluded.

Nov. 16, 2021, 6:30 p.m. usa

history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. subjects with cardiovascular disease subjects with diabetes subjects with pulmonary diseases such as copd or asthma history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) clinically significant abnormal electrocardiogram at screening. note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. positive serology results for hiv, hbsag, or hcv antibodies febrile illness with temperature ≥38°c within 7 days of dosing female subject who is pregnant or breastfeeding donated blood within 56 days of enrollment known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure treatment with another investigational drug within 28 days of dosing treatment with a monoclonal antibody within 3 months of enrollment positive serology results for sars-cov-2 antibodies. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements use of h1 antihistamines or beta-blockers within 5 days of dosing use of any prohibited medication within 28 days prior to screening or planned use during the study period note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period note: includes trials that have a study intervention such as a drug, biologic, or device is a study site employee or staff note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit)

history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. subjects with cardiovascular disease subjects with diabetes subjects with pulmonary diseases such as copd or asthma history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) clinically significant abnormal electrocardiogram at screening. note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. positive serology results for hiv, hbsag, or hcv antibodies febrile illness with temperature ≥38°c within 7 days of dosing female subject who is pregnant or breastfeeding donated blood within 56 days of enrollment known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure treatment with another investigational drug within 28 days of dosing treatment with a monoclonal antibody within 3 months of enrollment positive serology results for sars-cov-2 antibodies. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements use of h1 antihistamines or beta-blockers within 5 days of dosing use of any prohibited medication within 28 days prior to screening or planned use during the study period note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period note: includes trials that have a study intervention such as a drug, biologic, or device is a study site employee or staff note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit)

Sept. 27, 2021, 7:30 a.m. usa

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators 24. received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit)

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators 24. received an approved covid-19 vaccine (subjects can receive an approved covid-19 vaccine after completing their day 90 visit)

Nov. 26, 2020, 12:31 a.m. usa

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators

Oct. 26, 2020, 11:31 p.m. usa

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents; any vaccine (licensed or investigational) 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators

1. history of chronic medical condition that would either interfere with the accurate assessment of the objectives of the study or increase the risk profile of the subject. 2. subjects with cardiovascular disease 3. subjects with diabetes 4. subjects with pulmonary diseases such as copd or asthma 5. history of severe allergic reactions of any type to medications, bee stings, food, or environmental factors or hypersensitivity or reaction to immunoglobins. 6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 milliseconds) 7. clinically significant abnormal electrocardiogram at screening. - note: clinically significant abnormal ecg results include but not limited to: complete left or right bundle branch block; other ventricular conduction block; 2nd degree or 3rd degree atrioventricular (av) block; sustained ventricular arrhythmia; sustained atrial arrhythmia; two premature ventricular contractions in a row; pattern of st elevation felt consistent with cardiac ischemia; or any condition deemed clinically significant by a study investigator - incomplete right bundle branch block is not exclusionary if there are no abnormal ecg findings and there is no clinical history or evidence on physical examination to indicate cardiac disease. 8. positive serology results for hiv, hbsag, or hcv antibodies 9. febrile illness with temperature ≥38°c within 7 days of dosing 10. female subject who is pregnant or breastfeeding 11. donated blood within 56 days of enrollment 12. known allergic reactions to any of the study product components present in the formulation or in the processing, as listed in the investigator brochure 13. treatment with another investigational drug within 28 days of dosing 14. treatment with a monoclonal antibody within 3 months of enrollment 15. positive serology results for sars-cov-2 antibodies. 16. positive results from a reverse transcriptase polymerase chain reaction (rt pcr) test for sars cov 2 17. receipt of antibody (e.g. tig, vzig, ivig, im gamma globulin) or blood transfusion within 6 months or within 5 half-lives of the specific product given 18. active drug or alcohol use disorder or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 19. use of h1 antihistamines or beta-blockers within 5 days of dosing 20. use of any prohibited medication within 28 days prior to screening or planned use during the study period - note: prohibited medications include immunosuppressives (except nonsteroidal anti-inflammatory drugs [nsaids]); immune modulators; oral corticosteroids (topical/intranasal steroids are acceptable); anti-neoplastic agents; any vaccine (licensed or investigational) 21. any specific condition that in the judgment of the investigator precludes participation because it could affect subject safety 22. plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period - note: includes trials that have a study intervention such as a drug, biologic, or device 23. is a study site employee or staff - note: site employees or staff include the pis and sub-investigators or staff who are supervised by the pi or sub-investigators