Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy 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: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence rate of treatment-related adverse events

  Safety assessments based on reporting of Treatment Emergent Adverse Events

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

Secondary Outcomes (10)

• CMAX

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

• AUC

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

• TMAX

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

• Terminal elimination rate

  Enrollment up to the End of Study (SAD up to 12 months, MAD up to 18 months)

• Terminal elimination Half-life

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

Other Outcomes (5)

• Change from Baseline in Total Area Hair Count (TAHC)

  Enrollment and up to End of Study Visit (SAD 12 months, MAD 18 months)

• Change from Baseline in Total Area Hair Width (TAHW)

  Enrollment to the End of Study (SAD 12 months, MAD 18 months)

• Change From baseline Participant Self Assessment of Hair Growth

  Enrollment up to End of Study (SAD 12 months, MAD 18 months)

Study Arms (7)

SAD IV Dose 1 - 150mg ABS201 or Placebo

EXPERIMENTAL

ABS-201 IV Single Dose

Drug: ABS-201 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: ABS-201 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: ABS-201 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: ABS-201 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

ABS-201 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
• 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

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 (2)

Sinclair Dermatology

Melbourne, Victoria, 3002, Australia

NOT YET 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

Charles Romano, MPH

CONTACT

+1.860.857.4560; cromano@absci.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 4-6 SAD IV doses will be tested and if safe and well tolerated, approximately 3-4 Sub-cutaneous MAD doses will be tested in participants with or without AGA.

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: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)