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

NCT04468958 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SAB-185-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19; SARS-CoV2

Outcome Measures

Primary Outcomes (2)

• Number of Participants Having Adverse Events

  Incidence and severity of other adverse events and severe adverse events (SAE)

  29 Days

• Number of Participants Having Transfusion-Related Adverse Events

  transfusion-related adverse events

  29 Days

Secondary Outcomes (2)

• Number of Participants Having Adverse Events

  90 Days

• Pharmacokinetics from screening to day 90

  90 Days

Study Arms (5)

10mg/kg SAB-185

EXPERIMENTAL

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

Biological: SAB-185

25mg/kg SAB-185

EXPERIMENTAL

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

Biological: SAB-185

25mg/kg SAB-185 x 2 doses

EXPERIMENTAL

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.

Biological: SAB-185

50mg/kg SAB-185

EXPERIMENTAL

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

Biological: SAB-185

Placebo

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

SAB-185 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.

Also known as: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

10mg/kg SAB-185; 25mg/kg SAB-185; 25mg/kg SAB-185 x 2 doses; 50mg/kg SAB-185

Normal saline OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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-185.
• 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
• Receipt of pooled immunoglobulin or plasma in past 30 days
• 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
• Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)
• Positive screening test for hepatitis B virus surface antigen, hepatitis C virus antibody, or HIV antibody

Sponsors & Collaborators

• SAb Biotherapeutics, Inc.: lead
• Department of Health and Human Services: collaborator
• JPEO, Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB): collaborator

Study Sites (3)

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

SAB-185; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• David Hoover, MD

  ICON GPHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: July 1, 2020
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication and ending 36 months following article publication
• Access Criteria: Anyone who wishes to access the data.

Locations

US (3)