Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT04468958
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants
Sponsor:
SAb Biotherapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: