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.
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.
Biological: SAB-185
SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Other: Normal saline
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Inclusion Criteria:
Subjects must meet all of the following criteria for inclusion:
1. 18-60 years of age
2. Able to understand the study and comply with all study procedures
3. Agrees not to participate in any other trial of an investigational product during the
study period
4. Willing and able to provide written informed consent prior to the start of any study
related activities
5. In good health in the opinion of the site principal investigator as determined by
vital signs, medical history, physical examination and clinical laboratory tests
6. 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
7. Subjects agree to sexual abstinence (refraining from heterosexual intercourse for at
least 90 days following the last dose of study product) if not using birth control or
condoms for males.
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).
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
SUNY Upstate Medical University
Syracuse, New York, United States
ICON Early Phase Services
San Antonio, Texas, United States
David Hoover, MD, Principal Investigator
ICON GPHS