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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

NCT06435936 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • PHA1A

Interventions

DRUG

Single Ascending Dose of SAB-176

Single ascending dose

DRUG

Single Ascending Dose of Placebo

Single ascending dose

Sponsors & Collaborators

  • SAb Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nehkonti Adams, MD · Naval Medical Research Command (NMRC)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435936 on ClinicalTrials.gov