Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia

NCT ID: NCT07317544

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2028-07-31

Brief Summary

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

Androgenetic Alopecia (AGA); Healthy Volunteers - Male and Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAD IV Dose 1 - 150mg ABS201 or Placebo

ABS-201 IV Single Dose

Group Type: EXPERIMENTAL

ABS-201 IV Single Dose

Intervention Type: DRUG

ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),

Placebo IV

Intervention Type: DRUG

Matching placebo

SAD IV Dose 2 - 450mg ABS201 or Placebo

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Group Type: EXPERIMENTAL

ABS-201 IV Single Dose

Intervention Type: DRUG

ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),

Placebo IV

Intervention Type: DRUG

Matching placebo

SAD IV Dose 3 - 900mg ABS201 or Placebo

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Group Type: EXPERIMENTAL

ABS-201 IV Single Dose

Intervention Type: DRUG

ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),

Placebo IV

Intervention Type: DRUG

Matching placebo

SAD IV Dose 4 - 1800mg ABS201 or Placebo

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Group Type: EXPERIMENTAL

ABS-201 IV Single Dose

Intervention Type: DRUG

ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),

Placebo IV

Intervention Type: DRUG

Matching placebo

MAD SC Dose 1 - 300mg ABS201 or Placebo

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Group Type: EXPERIMENTAL

ABS-201 SC Multiple Doses

Intervention Type: DRUG

Multiple doses of ABS-201 for Subcutaneous injection

Placebo SC Injection

Intervention Type: DRUG

Subcutaneous Placebo injection for MAD arms

MAD SC Dose 2 - 600mg ABS201 or Placebo

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Group Type: EXPERIMENTAL

ABS-201 SC Multiple Doses

Intervention Type: DRUG

Multiple doses of ABS-201 for Subcutaneous injection

Placebo SC Injection

Intervention Type: DRUG

Subcutaneous Placebo injection for MAD arms

MAD SC Dose 2 - 1200mg ABS201 or Placebo

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Group Type: EXPERIMENTAL

ABS-201 SC Multiple Doses

Intervention Type: DRUG

Multiple doses of ABS-201 for Subcutaneous injection

Placebo SC Injection

Intervention Type: DRUG

Subcutaneous Placebo injection for MAD arms

Interventions

ABS-201 IV Single Dose

ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),

Intervention Type: DRUG

Placebo IV

Matching placebo

Intervention Type: DRUG

ABS-201 SC Multiple Doses

Multiple doses of ABS-201 for Subcutaneous injection

Intervention Type: DRUG

Placebo SC Injection

Subcutaneous Placebo injection for MAD arms

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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),

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Absci Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sinclair Dermatology

Melbourne, Victoria, Australia

Site Status: NOT_YET_RECRUITING

Nucleus Network

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Charles Romano, MPH

Role: CONTACT

cromano@absci.com

+1.860.857.4560

Other Identifiers

ABS-201-101

Identifier Type: -

Identifier Source: org_study_id