Protagenic Therapeutics, Inc. announced that it has completed enrollment and dosing in the multiple‑ascending‑dose (MAD) portion of its Phase 1 clinical study of its lead peptide candidate PT00114 in healthy volunteers. The company indicated the trial is designed to assess safety and tolerability after multiple sequential doses.
The firm stated that all healthy volunteers have now been dosed and that it expects to finalise and release topline safety results by the end of November 2025. Prior to this, the company had completed a single‑ascending‑dose study of the same candidate earlier in the year. Protagenic described PT00114 as a first‑in‑class therapeutic aimed at restoring resilience in individuals suffering from chronic stress and associated neurological consequences.
While the dosing completion represents a key early milestone, the company emphasised that the data remain limited to safety in healthy subjects and that further study will be required to determine efficacy in target patient populations.
