Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

NCT06393452 | Completed Phase 2 FDA Drug

• 1 other identifier: PP405-2001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetics of PP405

  Part 1: Baseline to Day 28; Part 2: Baseline-OLE to Day 84-OLE

Study Arms (3)

PP405 0.05% Topical Gel

ACTIVE COMPARATOR

0.05% Topical Gel applied once daily

Drug: PP405 0.05% Topical Gel

PP405 Topical Vehicle Gel

PLACEBO COMPARATOR

Placebo Topical Gel applied once daily

Drug: PP405 Topical Vehicle Gel

PP405 0.05% Topical Gel - Open Label Extension

OTHER

0.05% Topical Gel applied once daily for subjects who crossover into the Open-label Extension

Drug: PP405 0.05% Topical Gel

Interventions

PP405 Topical Vehicle Gel DRUG

PP405 Vehicle = placebo

PP405 Topical Vehicle Gel

PP405 0.05% Topical Gel DRUG

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

PP405 0.05% Topical Gel; PP405 0.05% Topical Gel - Open Label Extension

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects aged 18 to 55 years.
• Able and willing to provide written informed consent.
• 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.
• Agree to comply with protocol procedures

You may not qualify if:

• Concomitant diagnosis of non-AGA forms of alopecia.
• Use of other hair loss treatments within periods specified in protocol.
• Use of excluded medications as specified in protocol.
• Diagnosis of other medical conditions as specified in protocol.
• 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.

Sponsors & Collaborators

• Pelage Pharmaceuticals, Inc.: lead

Study Sites (8)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Clinical Trials Research Institute

Thousand Oaks, California, 91320, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Stride Clinical Research LLC

Sugar Land, Texas, 77479, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Gels

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Christina Weng

  Pelage Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who were randomized to vehicle in Part 1 will be eligible to participate in the Open-label Extension in Part 2 of the study.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: June 5, 2024
• Primary Completion: July 16, 2025
• Study Completion: October 1, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)