Androgenetic Alopecia (AGA)Phase 1/2NCT07327359
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
A Phase 1/2 study testing OLX72021 in people with Androgenetic Alopecia (AGA), run by Olix Pharmaceuticals, Inc. at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- OLX72021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Dec 2025to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
- History of substance abuse/dependence or recreational IV drug use within the past 2 years.
- 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.
- Previous treatment with the IP.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Australia6 sites, 6 recruiting
- Not yet recruiting
Emeritus Research Sydney
Botany, New South Wales, 2019
Professor Paul Bird, +61 289 648 186, info@emeritusresearch.com
- Recruiting
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Rafik Malik, MBBS, +613 9509 6166, info@emeritusresearch.com
- Not yet recruiting
Sinclair Dermatology (t/a DIRECT)
East Melbourne, Victoria, 3002
Laita Bokhari, +61 390 130 099, Laita.Bokhari@sinclairdermatology.com.au
Dr Samantha Eisman, MBChB, MCRP, FCDerm, FACD
- Not yet recruiting
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217
Nicola Miller, +61 295 874 277, nmiller.research@gmail.com
Dr Esther Hong, MBBS, MPhil, FACD
- Not yet recruiting
Institute for Skin, Health and Immunity
Mitcham, Victoria, 3132
Joshua Boland, +61 3 88389998, joshua.boland@ishi.net
Professor John Su, MBBS, FRACP
- Not yet recruiting
Genesis Research Services
Newcastle, New South Wales, 2292
Meaghan Weeks, +61 428 455 922, meaghan@genesisresearchservices.com
Dr Deon Smith, MBChB, FRACGP
New Zealand2 sites, 2 recruiting
- Not yet recruiting
Optimal Clinical Trials Central
Grafton, Auckland, 1010
Dr Tori Middlemiss, +6 493 034 987, tori@optimalclinicaltrials.com
- Not yet recruiting
Optimal Clinical Trials North Shore
North Shore, Auckland, 0627
Dr Claudette Lionnet, +6 493 034 987, clauette@optimalclinicaltrials.com
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- OLX72021, Placebo
- Keywords
- Male Pattern Hair Loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLX72021Drug
Low Dose
OLX72021Drug
Mid Dose
OLX72021Drug
High Dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b | Experimental | Phase 1b : 2 dose level cohorts. Participants receive a total of 3 intradermal treatments of OLX72021 or placebo 28 days apart Receives: 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 Receives: Drug: OLX72021; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs), assessed using the CTCAE Version 5.0 (Phase 1b)
Measured: From baseline to end of study (Day 85)
To assess local tolerability at intradermal (ID) injection site (Phase 1b)
Measured: 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)
Measured: Baseline to Day 169
Secondary outcomes (14)
To measure time to plasma Cmax (Tmax) (Phase 1b)
Measured: From baseline to Day 58
To measure maximum observed plasma concentration (Cmax) (Phase 1b)
Measured: 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)
Measured: From baseline to Day 58
To measure area under the plasma concentration-time curve from 0 to infinity (AUCinf) (Phase 1b)
Measured: From baseline to Day 58
To measure apparent terminal elimination half-life (t1/2) (Phase 1b)
Measured: From baseline to Day 58
To measure total apparent body clearance (CL/F) (Phase 1b)
Measured: From baseline to Day 58
To measure apparent volume of distribution (Vz/F) (Phase 1b)
Measured: From baseline to Day 58
To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at Day 29, Day 57, Day 85, Day 113, and Day 141 (Phase 2a)
Measured: From baseline to Day 141
To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs) (Phase 2a)
Measured: From baseline to end of study (Day 169)
To investigate the local tolerability at intradermal (ID) injection site (Phase 2a)
Measured: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 29, 57, 85, 113, 141 and 169 in the Men's Hair Growth Questionnaire© (MHGQ) (Phase 2a)
Measured: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 1, 29, 57, 85, 113, 141 and 169 in the Canfield Male Pattern Hair Loss - Patient Reported Outcome (CMPHL-PRO) (Phase 2a)
Measured: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 1, 29, 57, 85, 113, 141 and 169 in the Modified-Skindex-Mini (Phase 2a)
Measured: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 29, 57, 85, 113, 141 and 169 in the Investigator Global Assessment (IGA) (Phase 2a)
Measured: From baseline to end of study (Day 169)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start4 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327359
- Sponsor's protocol ID
- OLX72021-02
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07327359
- Acronym / sponsor ID
- OLX72021-02
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- Male Pattern Hair Loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Olix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b | Experimental | Drug: OLX72021Phase 1b : 2 dose level cohorts. Participants receive a total of 3 intradermal treatments of OLX72021 or placebo 28 days apart |
| Phase 2a | Experimental | Drug: OLX72021, Drug: PlaceboPhase 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Non-smoker.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLX72021Low Dose | Drug | Phase 2a |
| OLX72021Mid Dose | Drug | Phase 1b, Phase 2a |
| OLX72021High Dose | Drug | Phase 1b, Phase 2a |
| PlaceboPlacebo | Drug | Phase 2a |
Primary outcome
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)
To assess local tolerability at intradermal (ID) injection site (Phase 1b)
Time frame: 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)
Time frame: Baseline to Day 169
14 secondary outcomes
To measure time to plasma Cmax (Tmax) (Phase 1b)
Time frame: From baseline to Day 58
To measure maximum observed plasma concentration (Cmax) (Phase 1b)
Time frame: 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)
Time frame: From baseline to Day 58
To measure area under the plasma concentration-time curve from 0 to infinity (AUCinf) (Phase 1b)
Time frame: From baseline to Day 58
To measure apparent terminal elimination half-life (t1/2) (Phase 1b)
Time frame: From baseline to Day 58
To measure total apparent body clearance (CL/F) (Phase 1b)
Time frame: From baseline to Day 58
To measure apparent volume of distribution (Vz/F) (Phase 1b)
Time frame: From baseline to Day 58
To evaluate the change from baseline in non-vellus Target Area Hair Count (TAHC) at Day 29, Day 57, Day 85, Day 113, and Day 141 (Phase 2a)
Time frame: From baseline to Day 141
To investigate the incidence, type, severity, and relationship of adverse events (AEs)/serious AEs (SAEs) (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To investigate the local tolerability at intradermal (ID) injection site (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 29, 57, 85, 113, 141 and 169 in the Men's Hair Growth Questionnaire© (MHGQ) (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 1, 29, 57, 85, 113, 141 and 169 in the Canfield Male Pattern Hair Loss - Patient Reported Outcome (CMPHL-PRO) (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 1, 29, 57, 85, 113, 141 and 169 in the Modified-Skindex-Mini (Phase 2a)
Time frame: From baseline to end of study (Day 169)
To evaluate change from baseline at Days 29, 57, 85, 113, 141 and 169 in the Investigator Global Assessment (IGA) (Phase 2a)
Time frame: From baseline to end of study (Day 169)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OLX72021 in people with Androgenetic Alopecia (AGA), run by Olix Pharmaceuticals, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emeritus Research Chief Executive officer (+613 9509 6166, info@emeritusresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.