What is OLX72021 studying for androgenetic alopecia?

OLX72021 is being studied to assess its safety, how the body processes it, and its effects on hair loss in men with mild to moderate androgenetic alopecia. This clinical trial aims to evaluate different doses compared to placebo. The sponsor Olix Pharmaceuticals, Inc. leads this research to understand the drug's potential impact.

Who may be eligible for this androgenetic alopecia clinical trial?

Men aged 18 to 59 with mild to moderate androgenetic alopecia may be eligible. Participants must be medically healthy, non-smokers, and able to tolerate multiple injections. Certain medical conditions and recent treatments may disqualify some individuals. Please review eligibility criteria for more details.

Is there any cost to participate in this androgenetic alopecia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs associated with getting to the study site.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 59Years

MALE

Healthy Volunteers

ID07327359

Phase 1b2a Study to Assess Safety and Effectiveness of OLX72021 in Healthy Men With Androgenetic Alopecia

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

158

Participants Needed

Research Sites

47 weeks

Total Duration

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 1b2a 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 groupsincluding one placebo group and three OLX72021 dose groupswill 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 drugs 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

Age: 18Years - 59Years

MALE

Healthy Volunteers

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.

Research Team

Emeritus Research Chief Executive officer

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 1b2a Study to Assess Safety and Effectiveness of OLX72021 in Healthy Men With Androgenetic Alopecia

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria