Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

Pelage Pharmaceuticals, Inc.78 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Androgenetic Alopecia

Interventions

PP405 0.05% Topical GelDRUG

PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC)

PP405 Topical Vehicle GelDRUG

PP405 Vehicle = placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Clinical Trials Research Institute

Thousand Oaks, California, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Minnesota Clinical Study Center

Outcomes

Primary Outcomes

Percentage of subjects with treatment-related adverse events

Collection of adverse events, treatment emergent adverse events and serious adverse events.

Time frame: 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)

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

Secondary Outcomes

Pharmacokinetics of PP405

To assess the concentration of PP405 in plasma

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

Data from ClinicalTrials.gov

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