NCT07317544

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 227 (estimated)
• Sponsor: Absci Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

2 sites across 1 country: Australia