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

NCT07317544 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2026-05-22

No results posted yet for this study

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

Interventions

DRUG

ABS-201 IV Single Dose

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

DRUG

Placebo IV

Matching placebo

DRUG

ABS-201 SC Multiple Doses

Multiple doses of ABS-201 for Subcutaneous injection

DRUG

Placebo SC Injection

Subcutaneous Placebo injection for MAD arms

Sponsors & Collaborators

  • Absci Pty Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317544 on ClinicalTrials.gov