ABS-201 for improving hair growth in healthy adults and people with androgenetic alopecia

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ABS-201 in Healthy Adult Participants With and Without Androgenetic Alopecia

This trial will test whether ABS-201 is safe and helps hair grow in healthy adults and in men and women with androgenetic alopecia.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 227 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Absci Pty Ltd. (industry)
• Locations: 4 sites (Sydney, New South Wales and 3 other locations)
• Trial ID: NCT07317544 on ClinicalTrials.gov

What this trial studies

ABS-201 is being tested in a Phase 1/2, randomized, placebo-controlled design with single ascending IV doses and multiple ascending subcutaneous doses. The trial begins with healthy volunteers to establish safety and tolerability and then enrolls participants with androgenetic alopecia to explore effects on hair growth. Participants receive either ABS-201 or placebo and attend scheduled clinic visits for safety labs, ECGs, and scalp assessments over roughly one year. Standard scalp imaging and hair measurements will be used alongside clinical safety monitoring to track responses and adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults who are generally healthy, meet the Norwood-Hamilton III–V pattern for AGA (for the patient cohorts), have BMI 18–32 and weight >60 kg, can give informed consent, and can attend clinic visits and avoid pregnancy during the study.

Not a fit: People with other forms of hair loss (such as alopecia areata or scarring alopecia), significant medical problems, pregnant or breastfeeding individuals, or those outside the specified BMI/weight or pattern-stage criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ABS-201 could become a new systemic option to promote hair regrowth for people with androgenetic alopecia.

How similar studies have performed: This is an early-stage, novel therapy for AGA; established treatments remain topical minoxidil and oral finasteride, and comparable systemic biologic approaches have shown limited and mixed success so far.

Eligibility criteria

Inclusion 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 Inclusion criteria 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 Inclusion Criteria 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 diffuse thinning, or scarring alopecia) in the 6 months prior to screening.

Exclusion Criteria (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 \<40 or \>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:

  1. Topical minoxidil within 3 months before screening.
  2. Oral minoxidil other hair growth stimulators within 6 months before screening.
  3. Finasteride within 6 months before screening
  4. 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

Where this trial is running

Sydney, New South Wales and 3 other locations

• Momentum Darlinghurst — Sydney, New South Wales, Australia (RECRUITING)
• Nucleus Network Brisbane — Brisbane, Queensland, Australia (RECRUITING)
• Sinclair Dermatology — Melbourne, Victoria, Australia (NOT_YET_RECRUITING)
• Nucleus Network — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Charles Romano, MPH

Conditions: Androgenetic Alopecia, Healthy Volunteers - Male and Female, Hair Loss, AGA, Female hair loss, Male pattern baldness, hair regrowth