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New treatment option for Androgenetic Alopecia (AGA)
Official title Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia
ClinicalTrials.gov ID: NCT07317544
What this study is testing
What is ABS-201 IV Single Dose?
ABS-201 IV Single Dose 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
- The goal of this clinical trial is to learn if ABS-201 (a new medication) is safe and tolerable when used to improve hair growth in men and women. The trial will start with healthy volunteers and if safe, will treat participants with certain types of hair loss.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- (Major):
- Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical...
- Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analysis parameters
- Must have a body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening, with a total body weight \>60 kg.
- Participants, male and female, must be willing to avoid pregnancy for the duration of the trial.
You likely can't join if
- (Major):
- History or presence of cancer, except for basal cell carcinoma or cervical dysplasia successfully treated with no recurrence for ≥90 days before...
- History of liver disease, Gilbert's syndrome, or abnormal liver function tests (e.g., ALT, AST, or bilirubin \> ULN) at screening
- Systolic blood pressure ≤90 or ≥140 mmHg, diastolic BP ≤40 or ≥90 mmHg, pulse rate \ 100 bpm
- Positive test for HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Recent blood donation
See the full eligibility criteria
- (Major):
- Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical examination, and a 12-lead ECG.
- Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analysis parameters
- Must have a body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening, with a total body weight \>60 kg.
- Participants, male and female, must be willing to avoid pregnancy for the duration of the trial.
- Participants must be capable of giving signed informed consent
- Participants must have no signs or symptoms of active or latent tuberculosis (TB), Additional for patients with AGA:
- Diagnosis of AGA with a Norwood-Hamilton Scale III vertex to V pattern.
- Willing to clip target hair area for analysis and avoid scalp pigmentation products.
- Willingness to maintain approximately the same hair length at each study visit
- Additional for postmenopausal women with AGA: Diagnosis of AGA with a Ludwig Scale I-3, I-4, II-1, II-2 pattern, with a documented history of AGA for ≥12 months and no rapid progression (e.g., sudden shedding, acute...
- (Major):
- History or presence of cancer, except for basal cell carcinoma or cervical dysplasia successfully treated with no recurrence for ≥90 days before screening.
- History of liver disease, Gilbert's syndrome, or abnormal liver function tests (e.g., ALT, AST, or bilirubin \> ULN) at screening
- Systolic blood pressure ≤90 or ≥140 mmHg, diastolic BP ≤40 or ≥90 mmHg, pulse rate \ 100 bpm
- Positive test for HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Recent blood donation
- Any clinically significant psychiatric disorder
- Pregnant or breastfeeding females or those planning pregnancy during the study.
- History of postpartum depression, perimenopausal mood instability, or estrogen withdrawal syndrome Additional Exclusion criteria for participants with AGA undergoing hair assessments:
- Prior use of hair loss treatments:
- Topical minoxidil within 3 months before screening.
- Oral minoxidil other hair growth stimulators within 6 months before screening.
- Finasteride within 6 months before screening
- Dutasteride within 12 months before screening.
- Use of GLP-1 receptor agonists (e.g., semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, or similar agents) within 3 months prior to screening
- History of hair transplantation or other major scalp procedures or planned procedures during the study.
- Use of hair extensions, wigs, hairpieces, weaves, or any other artificial hair enhancement methods within 30 days prior to screening and throughout the study.
- History of clinically significant dermatologic disease of the scalp that could interfere with hair assessments or target area imaging
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Melbourne, 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Melbourne, 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.