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

NCT07317544 | Recruiting Phase 1

• 1 other identifier: ABS-201-101
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 4

Brief Summary

This is a first-in-human study of ABS-201, a new investigational medicine, in healthy adult men and women. Its main purpose is to find out whether ABS-201 is safe and well tolerated, as well as to understand how the body processes it and how it affects related biological markers. ABS-201 is being developed as a possible treatment for androgenetic alopecia (male- and female-pattern hair loss); its effect on hair growth has not yet been established. The study has two parts: in the single ascending dose (SAD) part, healthy adults receive one intravenous dose of ABS-201 or placebo; and in the multiple ascending dose (MAD) part, participants (including men with androgenetic alopecia) receive several subcutaneous doses of ABS-201 or placebo. The MAD part also evaluates the effect of ABS-201 on hair growth. 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 12 months in the single ascending dose (SAD) part and approximately 18 months in the multiple ascending dose (MAD) part. In the MAD part, participants receive repeated subcutaneous doses.

Conditions

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

Keywords

Androgenetic Alopecia; Hair Loss; AGA; Female hair loss; Male pattern baldness; hair regrowth

Outcome Measures

Primary Outcomes (1)

• Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs

  Safety assessments based on reporting of Treatment Emergent Adverse Events, together with clinically significant changes in vital signs, 12-lead ECG parameters, physical examination findings and clinical safety laboratory tests, and change in neurobehavioral symptoms (PHQ-9 and GAD-7).

  From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)

Secondary Outcomes (5)

• Pharmacokinetics (PK)

  From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)

• Pharmacodynamics (PD)

  From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)

• Immunogenicity

  From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)

• Target Area Hair Count (TAHC) (MAD; participants with AGA)

  Baseline to Week 26

• Total Area Hair Width (TAHW) (MAD cohort; participants with AGA)

  Baseline to week 26

Study Arms (7)

SAD IV Dose 1 - 150mg ABS201 or Placebo

EXPERIMENTAL

ABS-201 IV Single Dose

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV

SAD IV Dose 2 - 450mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV

SAD IV Dose 3 - 900mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV

SAD IV Dose 4 - 1800mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV

MAD SC Dose 1 - 300mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection

MAD SC Dose 2 - 600mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection

MAD SC Dose 2 - 1200mg ABS201 or Placebo

EXPERIMENTAL

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

Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection

Interventions

SAD IV Dose 1 - 150mg ABS201 IV Single Dose DRUG

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

SAD IV Dose 1 - 150mg ABS201 or Placebo; SAD IV Dose 2 - 450mg ABS201 or Placebo; SAD IV Dose 3 - 900mg ABS201 or Placebo; SAD IV Dose 4 - 1800mg ABS201 or Placebo

Placebo IV DRUG

Matching placebo

SAD IV Dose 1 - 150mg ABS201 or Placebo; SAD IV Dose 2 - 450mg ABS201 or Placebo; SAD IV Dose 3 - 900mg ABS201 or Placebo; SAD IV Dose 4 - 1800mg ABS201 or Placebo

ABS-201 SC Multiple Doses DRUG

Multiple doses of ABS-201 for Subcutaneous injection

MAD SC Dose 1 - 300mg ABS201 or Placebo; MAD SC Dose 2 - 1200mg ABS201 or Placebo; MAD SC Dose 2 - 600mg ABS201 or Placebo

Placebo SC Injection DRUG

Subcutaneous Placebo injection for MAD arms

MAD SC Dose 1 - 300mg ABS201 or Placebo; MAD SC Dose 2 - 1200mg ABS201 or Placebo; MAD SC Dose 2 - 600mg ABS201 or Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Biological males and biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Absci Pty Ltd.: lead

Study Sites (4)

Momentum Darlinghurst

Sydney, New South Wales, 2010, Australia

RECRUITING

Nucleus Network Brisbane

Brisbane, Queensland, 4006, Australia

RECRUITING

Sinclair Dermatology

Melbourne, Victoria, 3002, Australia

RECRUITING

Nucleus Network

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trial Information Desk

CONTACT

+1 360.949.1041; clinicaltrialinfo@absci.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending intravenous doses will be tested and, if safe and well tolerated, multiple ascending subcutaneous doses will be tested in participants with and without pattern hair loss.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 5, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)