Created at Source Raw Value Validated value
Aug. 17, 2021, 8:30 p.m. eu

1. Prior participation in SARS-CoV-2 vaccine, convalescent plasma, or mAb clinical trial. 2. Receipt of any investigational product within 30 days or 5 half-lives before the day of enrollment. 3. Is acutely ill or febrile 72 hours before or at Screening. Fever is defined as a body temperature ≥38.0°C (≥100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. 4. Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing). 5. Known allergy/sensitivity or hypersensitivity to the study drug, including excipients. 6. Is pregnant, as confirmed with a positive pregnancy test at Screening or on the day of dosing (Day 1), or breastfeeding. 7. Clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 8. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, autoimmune disease, or neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed. 9. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the Investigator, might confound the results of the study or confer an additional risk to the participant by their participation in the study.

1. Prior participation in SARS-CoV-2 vaccine, convalescent plasma, or mAb clinical trial. 2. Receipt of any investigational product within 30 days or 5 half-lives before the day of enrollment. 3. Is acutely ill or febrile 72 hours before or at Screening. Fever is defined as a body temperature ≥38.0°C (≥100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. 4. Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing). 5. Known allergy/sensitivity or hypersensitivity to the study drug, including excipients. 6. Is pregnant, as confirmed with a positive pregnancy test at Screening or on the day of dosing (Day 1), or breastfeeding. 7. Clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. 8. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, autoimmune disease, or neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed. 9. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the Investigator, might confound the results of the study or confer an additional risk to the participant by their participation in the study.