SAB-176 for Flu
(SAB-176-103 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Nehkonti Adams, MD
Principal Investigator
Naval Medical Research Command (NMRC)
Eligibility Criteria
Healthy adults who can receive an intramuscular injection are eligible for this trial. The study is not suitable for individuals with certain health conditions, but specific exclusion criteria are not listed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an intramuscular injection of SAB-176 or placebo on Day 1. Safety and pharmacokinetics are assessed.
Safety Monitoring
Participants are monitored for safety and adverse events for 60 days post-injection.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
Treatment Details
Interventions
- SAB-176
Find a Clinic Near You
Who Is Running the Clinical Trial?
SAb Biotherapeutics, Inc.
Lead Sponsor