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

NCT07327359 | Recruiting Phase 1 DMC

• 1 other identifier: OLX72021-02
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Androgenetic Alopecia (AGA)

Keywords

Male Pattern Hair Loss

Outcome Measures

Primary Outcomes (3)

• To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b)

  From baseline to end of study (Day 85)

• To assess local tolerability at intradermal (ID) injection site (Phase 1b)

  From baseline to end of study (Day 85)

• To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at 24 weeks (Day 169) (Phase 2a)

  Baseline to Day 169

Secondary Outcomes (10)

• To measure time to plasma Cmax (Tmax) (Phase 1b)

  From baseline to Day 58

• To measure maximum observed plasma concentration (Cmax) (Phase 1b)

  From baseline to Day 58

• To measure area under the plasma concentration-time curve from 0 to time of last quantifiable concentration (AUClast) (Phase 1b)

  From baseline to Day 58

• To measure area under the plasma concentration-time curve from 0 to infinity (AUCinf) (Phase 1b)

  From baseline to Day 58

• To measure apparent terminal elimination half-life (t1/2) (Phase 1b)

  From baseline to Day 58

Study Arms (2)

Phase 1b

EXPERIMENTAL

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

Drug: OLX72021

Phase 2a

EXPERIMENTAL

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

Drug: OLX72021; Drug: Placebo

Interventions

OLX72021 DRUG

Low Dose

Phase 2a

Placebo DRUG

Placebo

Phase 2a

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Olix Pharmaceuticals, Inc.: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (1)

Emeritus Research Camberwell

Camberwell, Victoria, 3124, Australia

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emeritus Research Chief Executive officer

CONTACT

+613 9509 6166; info@emeritusresearch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 8, 2026
• Study Start: December 4, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)