Actively Recruiting
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia
Led by Absci Pty Ltd. · Updated on 2026-05-08
227
Participants Needed
4
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The main questions it aims to answer are: What medical problems, if any, do participants experience when taking a single dose or many doses of ABS-201? How does the medication, ABS-201, compare to placebo (a look alike substance that does not contain any medication). Participants who qualify for the trial will receive either ABS-201 or a placebo, and visit the study clinic for scheduled checkups and tests for approximately 1 year.
CONDITIONS
Official Title
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be overtly healthy based on medical evaluation including history, physical exam, and ECG
- Normal hematology, clinical chemistry, coagulation tests, and urine analysis
- Body mass index (BMI) between 18 and 32 kg/m2, and total body weight over 60 kg
- Male and female participants must agree to avoid pregnancy during the trial
- Must be able to give signed informed consent
- No signs or symptoms of active or latent tuberculosis
- For androgenetic alopecia patients: diagnosis with Norwood-Hamilton Scale III vertex to V pattern
- Willing to clip target hair area for analysis and avoid scalp pigmentation products
- Willing to keep approximately the same hair length at each study visit
- For postmenopausal women with androgenetic alopecia: diagnosis with Ludwig Scale I-3, I-4, II-1, II-2 pattern and history of androgenetic alopecia for at least 12 months without rapid progression in the prior 6 months
You will not qualify if you...
- History or presence of cancer except 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 at screening
- Abnormal blood pressure or pulse rate outside specified ranges
- Positive test for HIV, hepatitis B, or hepatitis C
- Recent blood donation
- Any clinically significant psychiatric disorder
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of postpartum depression, perimenopausal mood instability, or estrogen withdrawal syndrome
- For androgenetic alopecia participants: prior use of topical minoxidil within 3 months, oral minoxidil or other hair growth stimulators within 6 months, finasteride within 6 months, or dutasteride within 12 months before screening
- Use of GLP-1 receptor agonists within 3 months before screening
- History of hair transplantation or major scalp procedures, or plans for such during the study
- Use of hair extensions, wigs, hairpieces, weaves, or other artificial hair enhancements within 30 days before screening and throughout the study
- History of significant scalp dermatologic diseases that could interfere with hair assessments or imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Momentum Darlinghurst
Sydney, New South Wales, Australia, 2010
Actively Recruiting
2
Nucleus Network Brisbane
Brisbane, Queensland, Australia, 4006
Actively Recruiting
3
Sinclair Dermatology
Melbourne, Victoria, Australia, 3002
Not Yet Recruiting
4
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Charles Romano, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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