NCT06393452

Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Pelage Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	PP405 0.05% Topical Gel	PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)
DRUG	PP405 Topical Vehicle Gel	PP405 Vehicle = placebo

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-07-16
• Completion: 2025-10-01
• First posted: 2024-05-01
• Last updated: 2025-12-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study