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A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo
Sponsor: SAb Biotherapeutics, Inc.
Summary
This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post prophylactic for influenza. This is a Phase 1, randomized, double-blind, placebo-controlled clinical trial in which a total of 28 subjects will receive an injection of either SAB-176 or placebo (normal saline). The investigational product will be administered intramuscularly (IM) on Day 1. Four dose escalation cohorts of 7 subjects (5 active and 2 placebo) each are planned. Subjects will be randomized to receive either SAB-176 or placebo in a double-blinded manner. Progression to subsequent dose-escalating cohorts will be dependent on safety measured through Day 5 after dosing of the previous cohort. Blood specimens will be collected at prescribed intervals to examine pharmacokinetics and immunogenicity. Safety will be actively monitored during investigational product administration and for 60 days following dosing. The decision to advance to the next cohort will be based solely on the safety assessment through Day 5. All safety data will be summarized and reviewed by the PI, the Sponsor's Clinical Monitor, and the Research Monitor prior to next cohort dose-escalation.
Official title: A Phase 1 Double-Blinded, Randomized, Placebo-Controlled Study Assessing Safety and Pharmacokinetics of Intramuscular SAB-176 (a Tc Bovine Derived Anti-Influenza Human Immunoglobulin) in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-04-22
Completion Date
2025-02-01
Last Updated
2024-09-19
Healthy Volunteers
Yes
Conditions
Interventions
Single Ascending Dose of SAB-176
Single ascending dose
Single Ascending Dose of Placebo
Single ascending dose
Locations (1)
Naval Medical Research Command (NMRC)
Bethesda, Maryland, United States