RecruitingPhase 1/2

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

Australia158 participantsStarted 2025-12-04

Plain-language 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.

Who can participate

Age range

18 Years – 59 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male. * 18 to 59 years. * Androgenetic Alopecia (Hamilton-Norwood III-V). * Body mass index (BMI) ≥ 18.0 kg/m2, with a body weight ≥ 50 kg at screening. * Non-smoker. * Medically healthy without clinically significant abnormalities. * Willing and able to tolerate multiple injections and attend all study visits. * Willing to have blood drawn. Exclusion Criteria: * History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant. * Uncontrolled diabetes mellitus. * Immunodeficiency disorders. * History of clinically significant heart disease. * History of risk factors for torsade de pointes. * Any dermatological disorders of the scalp. * History or clinical signs of keloids or hypertrophic scars. * History of active hair loss due to alopecia areata, scarring alopecia, diffuse telogen effluvium, or conditions other than AGA. * History of surgical correction of hair loss or hair transplant on the scalp. * History of radiation of the scalp at any time. * Use of semi-permanent hair products. * Use of an occlusive wig, hair extensions, or hair weaves for the duration of the study. * Use of cosmeceuticals or over-the-counter (OTC) hair regrowth products \< 2 weeks prior to the first dose of study drug. * Use of topical/local treatments. * Use of non-topical/…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b)

Timeframe: From baseline to end of study (Day 85)

To assess local tolerability at intradermal (ID) injection site (Phase 1b)

Timeframe: From baseline to end of study (Day 85)

To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at 24 weeks (Day 169) (Phase 2a)

Timeframe: Baseline to Day 169

Trial details

NCT IDNCT07327359

SponsorOlix Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Emeritus Research Chief Executive officer

+613 9509 6166 info@emeritusresearch.com

View on ClinicalTrials.gov More Androgenetic Alopecia (AGA) trials

Who can participate

Age range

18 Years – 59 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b)

Timeframe: From baseline to end of study (Day 85)

To assess local tolerability at intradermal (ID) injection site (Phase 1b)

Timeframe: From baseline to end of study (Day 85)

To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at 24 weeks (Day 169) (Phase 2a)

Timeframe: Baseline to Day 169