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

The registered record

Accession number

NCT07317544

Lead sponsor

Absci Pty Ltd. (industry)

Registered condition naming hair loss

Androgenetic Alopecia (AGA)

Also registered on this record

Healthy Volunteers - Male and Female

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 Adult Participants With and Without Androgenetic Alopecia

The first row holds the registered condition that placed this trial on the pipeline; the second holds everything else the sponsor registered on the same record. Both are shown, and shown apart rather than shaded differently, because leaving the second out would make this trial look more like a hair-loss study than its registration says it is — and because a distinction carried only by colour is not a distinction for every reader.

Interventions

• DrugSAD IV Dose 1 - 150mg ABS201 IV Single Dose
• DrugPlacebo IV
• DrugABS-201 SC Multiple Doses
• DrugPlacebo SC Injection

Names and types as registered. The sponsors' free-text descriptions of these interventions are not reproduced: they are written by the party with an interest in the result, and reprinting them inside this site's layout would lend them this site's voice.

Design

Study type

interventional

Phase

Phase 1/2

Allocation

randomized

Masking

quadruple

Primary purpose

treatment

Enrolment

227 participants (estimated)

Sites

4 locations in Australia

What it measures

1. Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs

   Time frame: From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)

Primary outcome measures only, as registered. What a trial chose to measure, and when, is the most informative thing about it that is knowable before it reports — a hair-count endpoint at 24 weeks and a patient-satisfaction endpoint at 12 weeks are not the same study.

Who can take part

Sex

all

Age

18 Years to 65 Years

Healthy volunteers

accepted

A summary of three registered fields, not the eligibility criteria. The full inclusion and exclusion criteria, the recruiting sites and the study contacts are on the registry record, which is the only place they are maintained. This site has no relationship with this trial and cannot refer anyone to it.

Registered dates

Study start

3 December 2025 (actual)

Primary completion

July 2028 (estimated)

Study completion

July 2028 (estimated)

First posted

5 January 2026 (actual)

Last update posted

3 September 2026 (actual)

"Estimated" and "actual" are the registry's own labels: an estimated date is a plan, and plans move. A date is printed at the precision it was registered at: a primary completion registered as 2028-07 is a month, and rendering it as 1 July 2028 would invent a day the sponsor did not register.

Results

This trial has not reported results. ClinicalTrials.gov holds no results record for it. That is the ordinary state of a trial that is running or about to run, and it means there is nothing here to tell you about whether the intervention works — including nothing negative. If this page implied otherwise it would be wrong.

On this site

Guides covering the condition this trial is registered for. They are about published evidence; this page is about a registration, and the two do not overlap.

Androgenetic Alopecia: Complete GuideNew Hair Loss Treatments in Clinical Trials: Clascoterone, Pyrilutamide and What the Published Data Actually ShowComplete Guide to Finasteride for Hair LossMinoxidil 5% Complete Guide: How to Apply for Best Results

Where this came from

Read from the ClinicalTrials.gov API on 6 September 2026 and rebuilt into this page without alteration. ClinicalTrials.gov is a service of the U.S. National Library of Medicine and is the authority on this record; where this page and the registry disagree, the registry is right. This page is not affiliated with or endorsed by NLM or NIH, or with the sponsor of this trial.

Open NCT07317544 on ClinicalTrials.gov · All 157 trials in the pipeline