Health TrialsbyHealthPanel

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

ConditionAndrogenetic Alopecia (AGA)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-59
SponsorOlix Pharmaceuticals, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OLX72021

    Drug

    Low Dose

  • OLX72021

    Drug

    Mid Dose

  • OLX72021

    Drug

    High Dose

  • Placebo

    Drug

    Placebo

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Phase 1bExperimental treatment 1 intervention
Group B: Phase 2aExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From baseline to end of study (Day 85)
2

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

Time frame
From baseline to end of study (Day 85)
3

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

Time frame
Baseline to Day 169

Secondary outcomes

1

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

Time frame
From baseline to Day 58
2

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

Time frame
From baseline to Day 58
3

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

Time frame
From baseline to Day 58
4

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

Time frame
From baseline to Day 58

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olix Pharmaceuticals, Inc.

Lead sponsor

Avance Clinical Pty Ltd.

Collaborator

Source ClinicalTrials.gov
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