A Phase 1/2 interventional study of SAD IV Dose 1 - 150mg ABS201 IV Single Dose and Placebo IV in Androgenetic Alopecia (AGA) and Healthy Volunteers - Male and Female, sponsored by Absci Pty Ltd.. Recruiting at 4 sites in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Absci Pty Ltd. · Phase 1/2, Interventional, and Treatment
This is a first-in-human study of ABS-201, a new investigational medicine, in healthy adult men and women. Its main purpose is to find out whether ABS-201 is safe and well tolerated, as well as to understand how the body processes it and how it affects related biological markers. ABS-201 is being developed as a possible treatment for androgenetic alopecia (male- and female-pattern hair loss); its effect on hair growth has not yet been established. The study has two parts: in the single ascending dose (SAD) part, healthy adults receive one intravenous dose of ABS-201 or placebo; and in the multiple ascending dose (MAD) part, participants (including men with androgenetic alopecia) receive several subcutaneous doses of ABS-201 or placebo. The MAD part also evaluates the effect of ABS-201 on hair growth.
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 12 months in the single ascending dose (SAD) part and approximately 18 months in the multiple ascending dose (MAD) part. In the MAD part, participants receive repeated subcutaneous doses.
Additional Inclusion criteria for patients with AGA:
Exclusion Criteria (Major):
Additional Exclusion criteria for participants with AGA undergoing hair assessments:
•
Prior use of hair loss treatments:
Dutasteride within 12 months before screening.
ABS-201 IV Single Dose
Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose · Drug: Placebo IV
Single Intra-venous dose of active study drug or placebo in Healthy Volunteers
Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose · Drug: Placebo IV
Single Intra-venous dose of active study drug or placebo in Healthy Volunteers
Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose · Drug: Placebo IV
Single Intra-venous dose of active study drug or placebo in Healthy Volunteers
Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose · Drug: Placebo IV
Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA
Drug: ABS-201 SC Multiple Doses · Drug: Placebo SC Injection
Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA
Drug: ABS-201 SC Multiple Doses · Drug: Placebo SC Injection
Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA
Drug: ABS-201 SC Multiple Doses · Drug: Placebo SC Injection
ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR)
Matching placebo
Multiple doses of ABS-201 for Subcutaneous injection
Subcutaneous Placebo injection for MAD arms
Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs
Safety assessments based on reporting of Treatment Emergent Adverse Events, together with clinically significant changes in vital signs, 12-lead ECG parameters, physical examination findings and clinical safety laboratory tests, and change in neurobehavioral symptoms (PHQ-9 and GAD-7).
Time frame: From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)
Pharmacokinetics (PK)
To investigate the pharmacokinetics (PK) characteristic of ABS201, Serum trough concentrations at each time point and descriptive statistics.
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Pharmacodynamics (PD)
Change from baseline in prolactin (PRL).
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Immunogenicity
Incidence of anti-drug antibodies (ADAs) and, in participants who develop ADAs, neutralizing antibodies (NAbs).
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Target Area Hair Count (TAHC) (MAD; participants with AGA)
Change from baseline in Total Area Hair Count (TAHC)
Time frame: Baseline to Week 26
Total Area Hair Width (TAHW) (MAD cohort; participants with AGA)
Change from baseline in Total Area Hair Width (TAHW)
Time frame: Baseline to week 26
Plan to share: No — The IPD sharing plan is not yet developed. The study team will consider data sharing at a later date.
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