Actively Recruiting
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
Led by Olix Pharmaceuticals, Inc. · Updated on 2026-03-06
158
Participants Needed
1
Research Sites
47 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
Researchers are evaluating OLX72021, a drug being studied for safety, tolerability, and how it behaves in the body in medically healthy men aged 18 to 59 years with mild to moderate androgenetic alopecia. This Phase 1b/2a double-blind, randomized, placebo-controlled trial aims to assess the effects of multiple doses of OLX72021 compared to placebo. The study will be conducted in two phases, with Phase 1b focusing on dose escalation and Phase 2a on expanded dosing groups. During Phase 1b, participants will receive three intradermal injections of OLX72021 or placebo, spaced 28 days apart, in sequential dose level cohorts involving 12 participants each. In Phase 2a, four groups—including one placebo group and three OLX72021 dose groups—will receive six intradermal treatments, also 28 days apart. The study evaluates up to two dose levels, with approximately 24 participants in Phase 1b and about 134 participants in Phase 2a. Participants will attend scheduled visits over the study period for assessments including safety monitoring, local injection site tolerability, and hair count measurements in target areas up to 24 weeks. Blood samples will be collected for pharmacokinetic analysis. The study will track adverse events and serious adverse events, as well as changes in hair count, to understand the drug's safety and effects. The total duration includes follow-ups to day 169 in Phase 2a.
CONDITIONS
Brief Title
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male.
- Age between 18 and 59 years.
- Diagnosed with androgenetic alopecia classified as Hamilton-Norwood III-V.
- Body mass index (BMI) at least 18.0 kg/m2 and body weight at least 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.
You will not qualify if you...
- History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, or neurological disease, including acute illness or major surgery within past 3 months.
- 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 signs of keloids or hypertrophic scars.
- History of active hair loss due to conditions other than androgenetic alopecia.
- History of surgical correction of hair loss or hair transplant on the scalp.
- History of scalp radiation.
- Use of semi-permanent hair products.
- Use of occlusive wigs, hair extensions, or hair weaves during study.
- Use of cosmeceuticals or over-the-counter hair regrowth products less than 2 weeks before first dose.
- Use of topical/local treatments.
- Use of non-topical/local medications within 24 weeks before first dose.
- Use of anticancer agents within 12 months before first dose.
- Scalp hair loss due to disease, injury, or medical therapy.
- Current infection requiring systemic or topical antibiotics, antifungals, antiparasitics, or antivirals.
- History of malignant disease in last 5 years (except certain skin cancers).
- Positive tests for HIV-1, HIV-2, hepatitis B or C.
- Positive drug, alcohol, or cotinine test at screening and before study drug administration.
- Vaccinations within 14 days before first dose.
- Blood or plasma donation within 30 days before first dose, or blood transfusion within 1 year.
- Treatment with investigational drug within 60 days or 5 half-lives prior to first dose.
- Any condition or prior therapy making participant unsuitable or likely to not comply.
- Known hypersensitivity to study drug or ingredients.
- Surgery or hospitalization within 3 months prior to screening or planned surgery during study.
- Regular consumption of more than 10 alcoholic drinks per week or more than 2 on any day.
- Refusal to provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on phase
Participants receive intradermal injections of OLX72021 or placebo. In Phase 1b, participants receive 3 treatments 28 days apart. In Phase 2a, participants receive 6 treatments 28 days apart.
3 to 6 visits (in-person) spaced 28 days apart
Duration - Up to 12 weeks after final treatment
Participants are monitored for safety, local tolerability, and efficacy outcomes after the last treatment.
Multiple visits for assessments up to Day 169
Trial Site Locations
Total: 1 location
1
Emeritus Research Camberwell
Camberwell, Victoria, Australia, 3124
Actively Recruiting
Research Team
E
Emeritus Research Chief Executive officer
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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