RecruitingPhase 1Phase 2NCT07317544

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

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

Sponsor

Absci Pty Ltd.

Enrollment

227 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Androgenetic alopecia (AGA)Healthy Volunteers - Male and Female

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABS-201 IV Single Dose, a drug called ABS-201 SC Multiple Doses, and others for people with androgenetic alopecia (aga) and healthy volunteers - male and female. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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