Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06393452
• Other study ID #: PP405-2001
• Status: Recruiting
• Phase: Phase 2
• Start date: June 5, 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Pelage Pharmaceuticals, Inc.
• Contact: Lisa Sherman
• Phone: 213-218-3830
• Email: clinicaltrials[@]pelagepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK following 28 days of administration.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• PP405 0.05% Topical Gel
PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)
• PP405 Topical Vehicle Gel
PP405 Vehicle = placebo

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Jordan Valley Dermatology Center	South Jordan	Utah
United States	Stride Clinical Research LLC	Sugar Land	Texas
United States	Clinical Trials Research Institute	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Pelage Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with treatment-related adverse events	Collection of adverse events, treatment emergent adverse events and serious adverse events.	Baseline to Day 28
Primary	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)	Baseline to Day 28
Secondary	Pharmacokinetics of PP405	To assess the concentration of PP405 in plasma	Baseline to Day 28