OLX72021 for men with male-pattern hair loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult male.
* 18 to 59 years.
* Androgenetic Alopecia (Hamilton-Norwood 3vertex, 4 or 5).
* 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.
* History of substance abuse/dependence or recreational IV drug use within the past 2 years.
* 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.
* Previous treatment with the IP.

Where it's running

• Emeritus Research Camberwell
  Camberwell, Victoria, Australia Recruiting
• Emeritus Research Sydney
  Botany, New South Wales, Australia Not yet recruiting
• St George Dermatology and Skin Cancer Centre
  Kogarah, New South Wales, Australia Not yet recruiting
• Genesis Research Services
  Newcastle, New South Wales, Australia Not yet recruiting
• Sinclair Dermatology (t/a DIRECT)
  East Melbourne, Victoria, Australia Not yet recruiting
• Institute for Skin, Health and Immunity
  Mitcham, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Emeritus Research Chief Executive officer
• Email: info@emeritusresearch.com
• Phone: +613 9509 6166

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.