Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants

Exclusion Criteria

• •1. Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
• •2. Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.
• •3. Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-185.
• •4. Subjects with the following risk factors:
• •* Compromised immune system including confirmed diagnosis of current cancer under treatment, inherited deficiencies of the immune system, immune suppressing medication, or other conditions causing leukopenia or neutropenia
• •* Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)
• •* Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen
• •* Chronic asthma requiring the use of oral steroids or hospitalization in the last six months
• •* Renal failure or renal insufficiency requiring dialysis
• •* Congestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease)
• •* Hypertension, diabetes, those currently vaping or smoking or with a history of chronic smoking, and those with BMI \> 35 kg/m2
• •5. Receipt of pooled immunoglobulin or plasma in past 30 days
• •6. Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185
• •7. Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)
• •8. Positive screening test for hepatitis B virus surface antigen, hepatitis C virus antibody, or HIV antibody
• •9. Positive screening test for rheumatoid factor
• •10. History of COVID-19
• •11. Positive FDA-authorized screening test for serum SARS-CoV-2 antibody or presence of SARS-CoV-2 on nasopharyngeal or oropharyngeal swab by FDA-authorized RT-PCR
• •12. History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin).