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Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia
Sponsor: Absci Pty Ltd.
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
ABS-201 IV Single Dose
ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),
Placebo IV
Matching placebo
ABS-201 SC Multiple Doses
Multiple doses of ABS-201 for Subcutaneous injection
Placebo SC Injection
Subcutaneous Placebo injection for MAD arms
Locations (2)
Sinclair Dermatology
Melbourne, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia