Oragenics Completes First Site Initiation for 40-Patient Phase IIa Trial
Oragenics has finished the first site initiation visit for its Phase IIa ONP-002 trial in Australia, completing staff training, protocol orientation and regulatory documentation at one of three sites. The randomized, placebo-controlled study aims to enroll 40 concussion patients across three Australian centers with dosing within 12 hours of injury.
1. First Site Initiation Completed
Oragenics completed its initial site initiation visit for the ONP-002 Phase IIa trial in Australia, executing staff training, protocol orientation and regulatory documentation at the first of three centers to launch clinical operations.
2. Remaining Sites Under Regulatory Review
The other two Australian sites are undergoing final Research Governance Office reviews following prior ethics approval, representing the last administrative step before each site can begin patient enrollment and dosing.
3. Phase IIa Trial Design Details
The randomized, placebo-controlled trial will enroll 40 concussion and mild traumatic brain injury patients across three sites, administer the first dose within 12 hours of injury, and evaluate safety, tolerability and preliminary neurocognitive outcomes.