women who are pregnant, breastfeeding or intending to become pregnant, or men intending to father children within the projected duration of the trial from screening until 14 days following last dose; currently participating in or has participated in a study with an investigational product (ip) within 30 days or 5 half-lives, whichever is longer, preceding day -1; due to the current pandemic: evidence of current sars-cov-2 infection (covid-19) based on testing at screening; documented prior covid-19 infection in the last 6 months; prior covid 19 infection with ongoing sequelae (i.e., long-hauler covid), or history of covid-19 infection requiring an intensive care unit stay or mechanical ventilation; current or history of the following medical conditions: respiratory disease requiring current medical intervention; hypersensitivity or severe allergic reactions to vaccines or drugs; diagnosis of diabetes mellitus or history of hypo- or hyperglycemia; clinically relevant hypertension; history or active diagnosis of renal disease secondary to diabetes, hypertension, vascular disease; history of bleeding diathesis or coagulopathy; cardiovascular diseases: i) qtcf ≥430 msec; history or family history of clinically significant or unstable ecg abnormalities (e.g., prolonged qt syndrome [torsade de pointes] or arrhythmias, including qt prolongation due to medical treatment), sudden cardiac death at a young age, or current use of a qt prolonging drug ii) angina; iii) congestive heart failure; iv) myocardial infarction within the previous 6 months; v) diastolic dysfunction; vi) coronary artery disease; h. malignancy within 5 years of screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence); immunosuppression as a result of underlying illness or treatment including: primary immunodeficiencies; long-term use (≥7 days) of oral or parenteral glucocorticoids; current or anticipated use of disease-modifying doses of antirheumatic drugs and biologic disease-modifying drugs, and no use of such drugs within the last 12 months; history of solid organ or bone marrow transplantation; prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune diseases; history of substance or alcohol abuse and positive urine drug testing at screening. subjects with a history of substance or alcohol abuse and negative urine drug testing at screening can be enrolled in study based on the investigator's discretion; any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study; functional disorders of the gastrointestinal (gi) tract and/or surgical procedures that have been conducted (e.g. bariatric surgery, cholecystectomy) which could preclude the ability to adequately allow for effective absorption, distribution, metabolism, or excretion of the drug; diagnostic assessments: a positive test pre-study for hepatitis c antibody, hepatitis b surface antigen (hbsag), or human immunodeficiency virus (hiv) antibody; hemoglobin a1c ≥uln; serum creatinine greater than or equal to uln; estimated glomerular filtration rate <90 ml/minute as calculated by the chronic kidney disease ckd-epi formula: gfr = 141 * min(scr/κ,1)α * max(scr/κ,1) -1.209 * 0.993age * 1.018 [if female] * 1.159 [if black] albumin to creatinine ratio (acr) ≥0.03 mg/mg. in the event of an acr above this threshold, eligibility must be confirmed by a second measurement; qualitative urinalysis test for blood, or glucose in urine. in the event of a positive test, the test will be repeated once, and if negative, the subject will be considered eligible; a positive pre-study drug screen or unwilling to refrain from use of the illicit drugs and adhere to other protocol-stated restrictions while participating in the study, including follow-up.

women who are pregnant, breastfeeding or intending to become pregnant, or men intending to father children within the projected duration of the trial from screening until 14 days following last dose; currently participating in or has participated in a study with an investigational product (ip) within 30 days or 5 half-lives, whichever is longer, preceding day -1; due to the current pandemic: evidence of current sars-cov-2 infection (covid-19) based on testing at screening; documented prior covid-19 infection in the last 6 months; prior covid 19 infection with ongoing sequelae (i.e., long-hauler covid), or history of covid-19 infection requiring an intensive care unit stay or mechanical ventilation; current or history of the following medical conditions: respiratory disease requiring current medical intervention; hypersensitivity or severe allergic reactions to vaccines or drugs; diagnosis of diabetes mellitus or history of hypo- or hyperglycemia; clinically relevant hypertension; history or active diagnosis of renal disease secondary to diabetes, hypertension, vascular disease; history of bleeding diathesis or coagulopathy; cardiovascular diseases: i) qtcf ≥430 msec; history or family history of clinically significant or unstable ecg abnormalities (e.g., prolonged qt syndrome [torsade de pointes] or arrhythmias, including qt prolongation due to medical treatment), sudden cardiac death at a young age, or current use of a qt prolonging drug ii) angina; iii) congestive heart failure; iv) myocardial infarction within the previous 6 months; v) diastolic dysfunction; vi) coronary artery disease; h. malignancy within 5 years of screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence); immunosuppression as a result of underlying illness or treatment including: primary immunodeficiencies; long-term use (≥7 days) of oral or parenteral glucocorticoids; current or anticipated use of disease-modifying doses of antirheumatic drugs and biologic disease-modifying drugs, and no use of such drugs within the last 12 months; history of solid organ or bone marrow transplantation; prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune diseases; history of substance or alcohol abuse and positive urine drug testing at screening. subjects with a history of substance or alcohol abuse and negative urine drug testing at screening can be enrolled in study based on the investigator's discretion; any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study; functional disorders of the gastrointestinal (gi) tract and/or surgical procedures that have been conducted (e.g. bariatric surgery, cholecystectomy) which could preclude the ability to adequately allow for effective absorption, distribution, metabolism, or excretion of the drug; diagnostic assessments: a positive test pre-study for hepatitis c antibody, hepatitis b surface antigen (hbsag), or human immunodeficiency virus (hiv) antibody; hemoglobin a1c ≥uln; serum creatinine greater than or equal to uln; estimated glomerular filtration rate <90 ml/minute as calculated by the chronic kidney disease ckd-epi formula: gfr = 141 * min(scr/κ,1)α * max(scr/κ,1) -1.209 * 0.993age * 1.018 [if female] * 1.159 [if black] albumin to creatinine ratio (acr) ≥0.03 mg/mg. in the event of an acr above this threshold, eligibility must be confirmed by a second measurement; qualitative urinalysis test for blood, or glucose in urine. in the event of a positive test, the test will be repeated once, and if negative, the subject will be considered eligible; a positive pre-study drug screen or unwilling to refrain from use of the illicit drugs and adhere to other protocol-stated restrictions while participating in the study, including follow-up.