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RECRUITING
NCT07317544
PHASE1/PHASE2

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

Sponsor: Absci Pty Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

227

Start Date

2025-12-03

Completion Date

2028-07

Last Updated

2026-01-05

Healthy Volunteers

Yes

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

Locations (2)

Sinclair Dermatology

Melbourne, Victoria, Australia

Nucleus Network

Melbourne, Victoria, Australia