Actively Recruiting
Study to Evaluate Safety and Tolerability of Single and Multiple Doses of ABS-201 in Adults With and Without Androgenetic Alopecia
Led by Absci Pty Ltd. · Updated on 2026-05-22
227
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ABS-201, a new medication designed to target the prolactin receptor, to see if it is safe and tolerable for improving hair growth in men and women. This trial includes healthy volunteers and participants with androgenetic alopecia (AGA), a common form of hair loss. The study aims to compare ABS-201 with a placebo to identify any medical problems caused by single or multiple doses of the drug. Participants will receive either a single intravenous dose or multiple subcutaneous doses of ABS-201 or placebo. The single-dose phase involves healthy volunteers receiving one of several intravenous doses ranging from 150mg to 1800mg. The multiple-dose phase includes patients with AGA receiving ascending subcutaneous doses from 300mg up to 1200mg. These treatments are given at scheduled times, and the trial is randomized and double-blind to ensure unbiased results. During the trial, participants will visit the study clinic for regular checkups, tests, and monitoring over approximately 12 to 18 months depending on the dosing phase. Researchers will track treatment-related adverse events, pharmacokinetics, and changes in hormone levels such as prolactin and IGF-1. These evaluations include blood tests, physical exams, and hair assessments. The study will also monitor immune responses and collect safety data throughout the trial period.
CONDITIONS
Brief 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 healthy based on medical evaluation including history, physical exam, and ECG
- Normal lab test results including hematology, chemistry, coagulation, and urine analysis
- Body mass index (BMI) between 18 and 32 kg/m2, weighing more than 60 kg
- Male and female participants willing to avoid pregnancy during the trial
- Able to give signed informed consent
- No signs or symptoms of active or latent tuberculosis
- Diagnosis of androgenetic alopecia with Norwood-Hamilton Scale III vertex to V pattern for men
- Willing to clip hair for analysis and avoid scalp pigmentation products
- Willing to keep approximately the same hair length at each visit
- Postmenopausal women with androgenetic alopecia must have Ludwig Scale I-3, I-4, II-1, or II-2 pattern with stable history for at least 12 months
You will not qualify if you...
- History or presence of cancer except basal cell carcinoma or treated cervical dysplasia without recurrence for at least 90 days
- History of liver disease, Gilbert's syndrome, or abnormal liver function tests
- Blood pressure outside the range of systolic 90-140 mmHg or diastolic 40-90 mmHg; pulse rate below 40 or above 100 bpm
- Positive test for HIV, hepatitis B, or hepatitis C
- Recent blood donation
- Any significant psychiatric disorder
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of postpartum depression, perimenopausal mood instability, or estrogen withdrawal syndrome
- Prior use of topical minoxidil within 3 months or oral minoxidil, finasteride within 6 months, and dutasteride within 12 months before screening
- Use of GLP-1 receptor agonists within 3 months before screening
- History or planned hair transplantation or major scalp procedures
- Use of hair extensions, wigs, or similar hair enhancement methods within 30 days before screening and throughout the study
- Dermatologic scalp disease that could interfere with hair assessments or imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive single or multiple ascending doses of the study drug or placebo administered intravenously or subcutaneously.
Multiple visits depending on dose and administration route
Duration - Up to 18 months
Participants are monitored for safety and treatment-related effects following dosing.
Regular follow-up visits as scheduled by the study team
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
Actively Recruiting
4
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Charles Romano, MPH
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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