NCT06870240View on ClinicalTrials.gov

A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

January 1, 2026

Study Completion Date

March 31, 2026

Conditions
Mild Traumatic Brain Injury, Concussion
Interventions
DRUG

Neurosteroid enantiomer

A non-natural synthetic neurosteroid enantiomer considered a new chemical entity

Trial Locations (1)

3181

Alfred Hospital, Melbourne

Sponsors

Lead Sponsor

Oragenics, Inc.
All Listed Sponsors
lead

Oragenics, Inc.

INDUSTRY

NCT06870240 - A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury | Biotech Hunter | Biotech Hunter