Loading clinical trials...

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects

NCT04468958•SAb Biotherapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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
+1 more criteria

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)
+9 more criteria

Locations (3)

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

Key Dates

Start Date

July 1, 2020

Primary Completion Date

December 23, 2020

Completion Date

December 23, 2020

Last Updated

July 1, 2022

Enrollment

ACTUAL participants

Conditions

COVID-19SARS-CoV2

Interventions

SAB-185

BIOLOGICAL

Normal saline

OTHER

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Dime La VerDAD: Verify, Debunk, and Disseminate

Positron Emission Tomography (PET) Imaging of Thrombosis