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 5 sites in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 227 is above the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with Absci Pty Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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