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NCT06435936 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo
A Phase 1 study of PHA1A, sponsored by SAb Biotherapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06435936: Active Phase 1 study of PHA1A, sponsored by SAb Biotherapeutics.
NCT06435936 is a Phase 1 study of PHA1A that is active but no longer recruiting, run by SAb Biotherapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06435936, a Phase 1 study of PHA1A, is active but no longer recruiting, sponsored by SAb Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Conditions Studied
Interventions
- DRUG Single Ascending Dose of SAB-176
- DRUG Single Ascending Dose of Placebo
Study Locations (1)
Maryland
- Naval Medical Research Command (NMRC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-04-22 |
| Est. Completion | 2025-02-01 |
| Phase | Phase 1 |
What the registry record for NCT06435936 still lists
NCT06435936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 1 condition, with PHA1A appearing as the primary indexed condition, and to 2 interventions - of which Single Ascending Dose of SAB-176 is the first listed.
NCT06435936 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06435936 about?
NCT06435936 is a clinical study titled "A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo". 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...
What is the current status of trial NCT06435936?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-04-22. Estimated completion is 2025-02-01.
What conditions does trial NCT06435936 study?
This clinical trial studies the following conditions: PHA1A.
What interventions are being tested in trial NCT06435936?
The interventions under investigation include: Single Ascending Dose of SAB-176 (DRUG), Single Ascending Dose of Placebo (DRUG).
Who is sponsoring clinical trial NCT06435936?
This trial is sponsored by SAb Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06435936 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06435936's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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