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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

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Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 19 May 2025

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At a glance

  • Drugs PRV-002 (Primary)
  • Indications Concussion; Traumatic brain injuries
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Oragenics Inc

Most Recent Events

  • 13 May 2025 According to an Oragenics Inc media release, company announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial evaluating ONP-002 for the treatment of mild traumatic brain injury (mTBI), aka concussion.
  • 09 Apr 2025 According to an Oragenics Inc media release, The trial is expected to be conducted at Christchurch Hospital in New Zealand,
  • 09 Apr 2025 According to an Oragenics Inc media release, Company has submitted a clinical trial protocol for regulatory review to the Health and Disability Ethics Committee (HDEC) in New Zealand.

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