Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 3:01 AM
Study NCT ID:
NCT07327359
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
Sponsor:
Olix Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: