A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- SAb Biotherapeutics, Inc.
- Enrollment
- 28
- Locations
- 3
- Primary Endpoint
- Number of Participants Having Adverse Events
Overview
Brief Summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Detailed Description
There were 4 treatment groups and 1 control group. Cohort 1 received 1 dose of SAB-185 at 10 mg/kg per dose. Cohort 2 received 1 dose of SAB-185 at 25 mg/kg, Cohort 3 received 2 doses of SAB-185 at 25 mg/kg each 7 days apart, and Cohort 4 received 1 dose of SAB-185 at 50 mg/kg per dose. All the doses were prepared at the site by the pharmacy staff or designee for delivery to the clinical staff for administration, per the site's SOPs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must meet all of the following criteria for inclusion:
- •18-60 years of age
- •Able to understand the study and comply with all study procedures
- •Agrees not to participate in any other trial of an investigational product during the study period
- •Willing and able to provide written informed consent prior to the start of any study related activities
- •In good health in the opinion of the site principal investigator as determined by vital signs, medical history, physical examination and clinical laboratory tests
- •If female, meets at least one of the following reproductive risk criteria
- •Post-menopausal for at least 12 months
- •Use of one or more of the following highly effective contraceptive methods for at least 90 days following the last dose of study product: combined estrogen and progestogen containing or progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system, surgical bilateral tubal occlusion
- •Vasectomized sole sexual partner who has received medical assessment of the surgical success
Exclusion Criteria
- •Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- •Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.
- •Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-
- •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)
Outcomes
Primary Outcomes
Number of Participants Having Adverse Events
Time Frame: 29 Days
Incidence and severity of other adverse events and severe adverse events (SAE)
Number of Participants Having Transfusion-Related Adverse Events
Time Frame: 29 Days
transfusion-related adverse events
Secondary Outcomes
- Pharmacokinetics from screening to day 90(90 Days)
- Number of Participants Having Adverse Events(90 Days)