OLX72021 for men with male-pattern hair loss

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

This research will test whether OLX72021 is safe and may help men aged 18 to 59 with mild to moderate male-pattern hair loss.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 59 Years
• Sex: Male
• Sponsor: Olix Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Camberwell, Victoria)
• Trial ID: NCT07327359 on ClinicalTrials.gov

What this trial studies

OLX72021 is being tested in a double-blind, randomized, placebo-controlled Phase 1b/2a multiple ascending-dose design to measure safety, tolerability, pharmacokinetics, and early efficacy signals in men with Hamilton-Norwood III-V androgenetic alopecia. Phase 1b will enroll small sequential cohorts of 12 participants (9 active, 3 placebo) to determine tolerability and PK at up to two dose levels. Phase 2a will expand into larger cohorts with approximately 134 participants per dose level and may dose cohorts concurrently. Participants will receive multiple injections and attend regular safety, PK, and hair-growth assessments at the study site.

Who should consider this trial

Good fit: Medically healthy, non-smoking men aged 18–59 with mild to moderate androgenetic alopecia (Hamilton-Norwood III–V), BMI ≥ 18 kg/m2 and weight ≥ 50 kg who can tolerate multiple injections and study visits.

Not a fit: Men with scarring scalp disorders, active autoimmune hair loss, significant medical illnesses (including uncontrolled diabetes, immunodeficiency, or major cardiac risk factors), a history of keloids or hypertrophic scarring, or who smoke are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, OLX72021 could provide a new injectable option that stimulates hair regrowth for men with androgenetic alopecia.

How similar studies have performed: Some early-phase programs for novel hair-loss agents have reported modest hair-growth signals, but OLX72021 is a novel compound and remains unproven in larger trials.

Eligibility criteria

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/local medications within 24 weeks prior to the first dose of study drug
* Anti-cancer agents, including cytotoxic agents, that can potentially have effects on alopecia within 12 months prior to the first dose of study drug
* Scalp hair loss on the treatment area due to disease, injury, or medical therapy.
* Current infection that requires systemically absorbed or topical antibiotic, antifungal, antiparasitic, or antiviral medications.
* Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
* Positive test results for active human immunodeficiency virus-1 or 2 (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
* Positive drugs of abuse test, alcohol breath test, or cotinine test at the screening visit and prior to the first administration of study treatment.
* Use of any vaccinations within 14 days prior to the first study drug administration.
* Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
* Treatment with an investigational drug in another clinical trial within 60 days or 5 half lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial.
* Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
* Known hypersensitivity to the study drug or any of the study drug ingredients.
* History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.
* Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 2 standard alcoholic drinks on any one day.
* Refusal to provide informed consent.

Where this trial is running

Camberwell, Victoria

• Emeritus Research Camberwell — Camberwell, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Emeritus Research Chief Executive officer

Conditions Androgenetic Alopecia; Male Pattern Hair Loss