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

OliX Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Androgenetic Alopecia (AGA)

Treatments: Drug: OLX72021; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07327359

OLX72021-02

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.

Full description

This is a Phase 1b/2a double-blind, randomized, placebo-controlled, multiple ascending dose study evaluating the safety, efficacy, and pharmacokinetics (PK) of OLX72021 at a maximum of 2 dose levels. In Phase 1b, evaluation of dose levels will be conducted in a sequential manner with lower dose levels evaluated first in the sequence. Each dose level will be evaluated in a cohort of 12 participants with 9 participants receiving OLX72021 and 3 participants receiving placebo, approximately 24 participants in total. Cohorts may be dosed concurrently in Phase 2a. Each dose level will be evaluated in approximately 134 participants receiving OLX72021 or placebo for Phase 2a.

Enrollment: 158 estimated patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

Phase 1b

Experimental group

Description:

Phase 1b : 2 dose level cohorts. Participants receive a total of 3 intradermal treatments of OLX72021 or placebo 28 days apart

Treatment:

Drug: OLX72021

Drug: OLX72021

Drug: OLX72021

Phase 2a

Experimental group

Description:

Phase 2a: 4 groups (1 group placebo and 3 groups with OLX72021). Participants receive 6 treatments of either placebo or OLX72021 via intradermal injection 28 days apart

Treatment:

Drug: Placebo

Drug: OLX72021

Drug: OLX72021

Drug: OLX72021