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

NCT ID: NCT04468958

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-23

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.

Conditions

COVID-19; SARS-CoV2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10mg/kg SAB-185

10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%)

Group Type: EXPERIMENTAL

SAB-185

Intervention Type: BIOLOGICAL

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.

25mg/kg SAB-185

25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)

Group Type: EXPERIMENTAL

SAB-185

Intervention Type: BIOLOGICAL

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.

25mg/kg SAB-185 x 2 doses

25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%). Cohort 3 will receive a second 25mg/kg dose of SAB-185 7 days (+/-2) after the first treatment.

Group Type: EXPERIMENTAL

SAB-185

Intervention Type: BIOLOGICAL

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.

50mg/kg SAB-185

50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%)

Group Type: EXPERIMENTAL

SAB-185

Intervention Type: BIOLOGICAL

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.

Placebo

Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Interventions

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.

Intervention Type: BIOLOGICAL

Normal saline

Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.

Intervention Type: OTHER

Other Intervention Names

Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

JPEO, Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)

UNKNOWN

Sponsor Role: collaborator

SAb Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hoover, MD

Role: PRINCIPAL_INVESTIGATOR

ICON GPHS

Locations

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

Countries

United States

Other Identifiers

SAB-185-101

Identifier Type: -

Identifier Source: org_study_id