Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Condition(s) studied
Investigational drug(s) / intervention(s)
SAD IV Dose 1 - 150mg ABS201 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
Study summary
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.
Eligibility
Primary outcome measure(s)
- Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs — From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)
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).
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Momentum Darlinghurst | Sydney | New South Wales | Recruiting |
| Nucleus Network Brisbane | Brisbane | Queensland | Recruiting |
| Sinclair Dermatology | Melbourne | Victoria | Recruiting |
| Nucleus Network | Melbourne | Victoria | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07317544 on ClinicalTrials.gov ↗ ← All trials in Australia