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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: PP405 0.05% Topical Gel; Drug: PP405 Topical Vehicle Gel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Thousand Oaks, California, United States, 91320
      • Clinical Trials Research Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch
    • Sugar Land, Texas, United States, 77479
      • Stride Clinical Research LLC
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female subjects aged 18 to 55 years.
2. Able and willing to provide written informed consent.
3. Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
4. Agree to comply with protocol procedures

Exclusion Criteria:

1. Concomitant diagnosis of non-AGA forms of alopecia.
2. Use of other hair loss treatments within periods specified in protocol.
3. Use of excluded medications as specified in protocol.
4. Diagnosis of other medical conditions as specified in protocol.
5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PP405 0.05% Topical Gel; 0.05% Topical Gel applied once daily	Drug: PP405 0.05% Topical Gel; PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)
Placebo Comparator: PP405 Topical Vehicle Gel; Placebo Topical Gel applied once daily	Drug: PP405 Topical Vehicle Gel; PP405 Vehicle = placebo
Other: PP405 0.05% Topical Gel - Open Label Extension; 0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension	Drug: PP405 0.05% Topical Gel; PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with treatment-related adverse events	Collection of adverse events, treatment emergent adverse events and serious adverse events.	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE
Change in local dermal tolerability as assessed by subject and investigator	Collection of local skin reactions using a 4 point scale (0-none, 1-mild, 2-moderate, 3-severe)	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of PP405	To assess the concentration of PP405 in plasma	Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

Collaborators and Investigators

• Sponsor: Pelage Pharmaceuticals, Inc.
• Investigators: Study Chair: Christina Weng, Pelage Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Gels
• Other Study ID Numbers: PP405-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No