BridgeMD
Tests treatment safety and results for Androgenetic Alopecia (AGA)
Official title A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic Alopecia
ClinicalTrials.gov ID: NCT07327359
What this study is testing
What is OLX72021?
OLX72021 is an investigational medicine, being studied as a potential treatment for androgenetic alopecia (aga).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of OLX72021 in medically healthy men with mild to moderate androgenetic alopecia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, or neurological disease...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Camberwell, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camberwell, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.