NCT07327359

A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase 1b/2a Study to Evaluate the Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Olix Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.

Detailed description

This is a Phase 1b/2a double-blind, randomized, placebo-controlled, multiple ascending dose study evaluating the safety, efficacy, and pharmacokinetics (PK) of OLX72021 at a maximum of 2 dose levels. In Phase 1b, evaluation of dose levels will be conducted in a sequential manner with lower dose levels evaluated first in the sequence. Each dose level will be evaluated in a cohort of 12 participants with 9 participants receiving OLX72021 and 3 participants receiving placebo, approximately 24 participants in total. Cohorts may be dosed concurrently in Phase 2a. Each dose level will be evaluated in approximately 134 participants receiving OLX72021 or placebo for Phase 2a.

Conditions

• Androgenetic Alopecia (AGA)

Interventions

Type	Name	Description
DRUG	OLX72021	Low Dose
DRUG	OLX72021	Mid Dose
DRUG	OLX72021	High Dose
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-04-01
• Completion: 2027-03-01
• First posted: 2026-01-08
• Last updated: 2026-03-06

Locations

1 site across 1 country: Australia