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Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

NCT06393452 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

DRUG

PP405 0.05% Topical Gel

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

DRUG

PP405 Topical Vehicle Gel

PP405 Vehicle = placebo

Sponsors & Collaborators

  • Pelage Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Christina Weng · Pelage Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2025-07-16
Completion
2025-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06393452 on ClinicalTrials.gov