Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 59Years
MALE
Healthy Volunteers
NCT07327359

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

Led by Olix Pharmaceuticals, Inc. · Updated on 2026-03-06

158

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

O

Olix Pharmaceuticals, Inc.

Lead Sponsor

A

Avance Clinical Pty Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 59Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male adults aged 18 to 59 years
  • Mild to moderate androgenetic alopecia (Hamilton-Norwood III-V)
  • Body mass index (BMI) of at least 18.0 kg/m2 and body weight of at least 50 kg at screening
  • Non-smokers
  • Medically healthy without clinically significant abnormalities
  • Willing and able to tolerate multiple injections and attend all study visits
  • Willing to have blood drawn
Not Eligible

You will not qualify if you...

  • History or presence of significant lung, liver, kidney, blood, digestive, hormone, immune, or neurological disease, including any acute illness or major surgery within 3 months
  • Uncontrolled diabetes mellitus
  • Immunodeficiency disorders
  • History of significant heart disease or risk factors for torsade de pointes
  • Any scalp skin disorders
  • History or signs of keloids or thick scars
  • Hair loss due to conditions other than androgenetic alopecia
  • Prior hair transplant or surgical correction of hair loss on the scalp
  • History of scalp radiation at any time
  • Use of semi-permanent hair products or occlusive wigs, extensions, or weaves during the study
  • Use of cosmeceuticals or over-the-counter hair regrowth products within 2 weeks before dosing
  • Use of topical or non-topical hair treatments within 24 weeks before dosing
  • Use of anti-cancer agents with alopecia effects within 12 months before dosing
  • Scalp hair loss due to disease, injury, or medical therapy
  • Current infections requiring systemic or topical antimicrobial medications
  • History of cancer within 5 years except certain skin cancers
  • Positive tests for HIV, hepatitis B or C
  • Positive drug, alcohol, or nicotine tests at screening and before dosing
  • Vaccinations within 14 days before dosing
  • Recent blood or plasma donations or transfusions
  • Treatment with other investigational drugs within 60 days or 5 half-lives before dosing
  • Any other condition or treatment making participation unsuitable
  • Known allergy to study drug or ingredients
  • Recent surgery or planned surgery during the study
  • Regular heavy alcohol consumption
  • Refusal to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emeritus Research Camberwell

Camberwell, Victoria, Australia, 3124

Actively Recruiting

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Research Team

E

Emeritus Research Chief Executive officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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