Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Summary

The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.

Timeline

Start

2024-06-05

Primary completion

2025-07-16

Completion

2025-10-01

Outcome

Met primary endpoint

release “PP405 met the primary safety endpoint and was well tolerated with no systemic absorption of PP405 detected in the blood and no systemic adverse events.” pelagepharma.com ↗

Drugs

Indications