Androgenetic Alopecia (AGA)Phase 1/2NCT07317544
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
A Phase 1/2 study testing SAD IV Dose 1 - 150mg ABS201 IV Single Dose and ABS-201 SC Multiple Doses in people with Androgenetic Alopecia (AGA) and Healthy Volunteers - Male and Female, run by Absci Pty Ltd. at 5 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
- What is being tested?
- SAD IV Dose 1 - 150mg ABS201 IV Single Dose and ABS-201 SC Multiple Doses
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 5 sitesAustralia
- Study dates
- 3 Dec 2025to Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical examination, and a 12-lead ECG.
- Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analysis parameters
- Participants, male and female, must be willing to avoid pregnancy for the duration of the trial.
- Participants must be capable of giving signed informed consent
- Participants must have no signs or symptoms of active or latent tuberculosis (TB),
- Additional Inclusion criteria for patients with AGA:
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- Diagnosis of AGA with a Norwood-Hamilton Scale III vertex to V pattern.
- Willing to clip target hair area for analysis and avoid scalp pigmentation products.
- Willingness to maintain approximately the same hair length at each study visit
Who cannot join
- History or presence of cancer, except for basal cell carcinoma or cervical dysplasia successfully treated with no recurrence for ≥90 days before screening.
- History of liver disease, Gilbert's syndrome, or abnormal liver function tests (e.g., ALT, AST, or bilirubin > ULN) at screening
- Systolic blood pressure ≤90 or ≥140 mmHg, diastolic BP ≤40 or ≥90 mmHg, pulse rate <40 or >100 bpm
- Positive test for HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Recent blood donation
- Any clinically significant psychiatric disorder
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- Pregnant or breastfeeding females or those planning pregnancy during the study.
- History of postpartum depression, perimenopausal mood instability, or estrogen withdrawal syndrome
- Additional Exclusion criteria for participants with AGA undergoing hair assessments:
- •
- Prior use of hair loss treatments:
- Topical minoxidil within 3 months before screening.
- Oral minoxidil other hair growth stimulators within 6 months before screening.
- Finasteride within 6 months before screening
- Dutasteride within 12 months before screening.
- Use of GLP-1 receptor agonists (e.g., semaglutide, liraglutide, dulaglutide, exenatide, tirzepatide, or similar agents) within 3 months prior to screening
- History of hair transplantation or other major scalp procedures or planned procedures during the study.
- Use of hair extensions, wigs, hairpieces, weaves, or any other artificial hair enhancement methods within 30 days prior to screening and throughout the study.
- History of clinically significant dermatologic disease of the scalp that could interfere with hair assessments or target area imaging
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Nucleus Network Brisbane
Brisbane, Queensland, 4006
- Recruiting
Sinclair Dermatology
Melbourne, Victoria, 3002
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
- Recruiting
DermCo Pty Ltd
South Perth, Western Australia
- Recruiting
Momentum Darlinghurst
Sydney, New South Wales, 2010
About this study
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
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:
Read more
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.
- Being tested
- SAD IV Dose 1 - 150mg ABS201 IV Single Dose, Placebo IV, ABS-201 SC Multiple Doses, Placebo SC Injection
- Keywords
- Androgenetic Alopecia, Hair Loss, AGA, Female hair loss, Male pattern baldness, hair regrowth
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAD IV Dose 1 - 150mg ABS201 IV Single DoseDrug
ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR)
Placebo IVDrug
Matching placebo
ABS-201 SC Multiple DosesDrug
Multiple doses of ABS-201 for Subcutaneous injection
Placebo SC InjectionDrug
Subcutaneous Placebo injection for MAD arms
| Study group | Role | What they receive |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 or Placebo | Experimental | ABS-201 IV Single Dose Receives: Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV |
| SAD IV Dose 2 - 450mg ABS201 or Placebo | Experimental | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers Receives: Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV |
| SAD IV Dose 3 - 900mg ABS201 or Placebo | Experimental | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers Receives: Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV |
| SAD IV Dose 4 - 1800mg ABS201 or Placebo | Experimental | Single Intra-venous dose of active study drug or placebo in Healthy Volunteers Receives: Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV |
| MAD SC Dose 1 - 300mg ABS201 or Placebo | Experimental | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA Receives: Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection |
| MAD SC Dose 2 - 600mg ABS201 or Placebo | Experimental | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA Receives: Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection |
| MAD SC Dose 2 - 1200mg ABS201 or Placebo | Experimental | Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA Receives: Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)
Secondary outcomes (5)
Pharmacokinetics (PK)
To investigate the pharmacokinetics (PK) characteristic of ABS201, Serum trough concentrations at each time point and descriptive statistics.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Baseline to Week 26
Total Area Hair Width (TAHW) (MAD cohort; participants with AGA)
Change from baseline in Total Area Hair Width (TAHW)
Measured: Baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start3 Dec 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single ascending intravenous doses will be tested and, if safe and well tolerated, multiple ascending subcutaneous doses will be tested in participants with and without pattern hair loss.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Absci Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317544
- Sponsor's protocol ID
- ABS-201-101
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD sharing plan is not yet developed. The study team will consider data sharing at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07317544
- Acronym / sponsor ID
- ABS-201-101
- Keywords
- Androgenetic Alopecia, Hair Loss, AGA, Female hair loss, Male pattern baldness, hair regrowth
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- Absci Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Single ascending intravenous doses will be tested and, if safe and well tolerated, multiple ascending subcutaneous doses will be tested in participants with and without pattern hair loss.
| Arm | Type | Receives |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 or Placebo | Experimental | Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose, Drug: Placebo IVABS-201 IV Single Dose |
| SAD IV Dose 2 - 450mg ABS201 or Placebo | Experimental | Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose, Drug: Placebo IVSingle Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 3 - 900mg ABS201 or Placebo | Experimental | Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose, Drug: Placebo IVSingle Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| SAD IV Dose 4 - 1800mg ABS201 or Placebo | Experimental | Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose, Drug: Placebo IVSingle Intra-venous dose of active study drug or placebo in Healthy Volunteers |
| MAD SC Dose 1 - 300mg ABS201 or Placebo | Experimental | Drug: ABS-201 SC Multiple Doses, Drug: Placebo SC InjectionMultiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 600mg ABS201 or Placebo | Experimental | Drug: ABS-201 SC Multiple Doses, Drug: Placebo SC InjectionMultiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
| MAD SC Dose 2 - 1200mg ABS201 or Placebo | Experimental | Drug: ABS-201 SC Multiple Doses, Drug: Placebo SC InjectionMultiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must be overtly healthy, as determined by medical evaluation, which includes a review of medical and surgical history, physical examination, and a 12-lead ECG.
- Must have normal ranges for hematology, clinical chemistry, coagulation tests, and urine analysis parameters
- Participants, male and female, must be willing to avoid pregnancy for the duration of the trial.
- Participants must be capable of giving signed informed consent
- Participants must have no signs or symptoms of active or latent tuberculosis (TB),
Key exclusion criteria (19 listed)
- History or presence of cancer, except for basal cell carcinoma or cervical dysplasia successfully treated with no recurrence for ≥90 days before screening.
- History of liver disease, Gilbert's syndrome, or abnormal liver function tests (e.g., ALT, AST, or bilirubin > ULN) at screening
- Systolic blood pressure ≤90 or ≥140 mmHg, diastolic BP ≤40 or ≥90 mmHg, pulse rate <40 or >100 bpm
- Positive test for HIV, hepatitis B (HBV), or hepatitis C (HCV).
- Recent blood donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAD IV Dose 1 - 150mg ABS201 IV Single DoseABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR) | Drug | SAD IV Dose 1 - 150mg ABS201 or Placebo, SAD IV Dose 2 - 450mg ABS201 or Placebo, SAD IV Dose 3 - 900mg ABS201 or Placebo, SAD IV Dose 4 - 1800mg ABS201 or Placebo |
| Placebo IVMatching placebo | Drug | SAD IV Dose 1 - 150mg ABS201 or Placebo, SAD IV Dose 2 - 450mg ABS201 or Placebo, SAD IV Dose 3 - 900mg ABS201 or Placebo, SAD IV Dose 4 - 1800mg ABS201 or Placebo |
| ABS-201 SC Multiple DosesMultiple doses of ABS-201 for Subcutaneous injection | Drug | MAD SC Dose 1 - 300mg ABS201 or Placebo, MAD SC Dose 2 - 1200mg ABS201 or Placebo, MAD SC Dose 2 - 600mg ABS201 or Placebo |
| Placebo SC InjectionSubcutaneous Placebo injection for MAD arms | Drug | MAD SC Dose 1 - 300mg ABS201 or Placebo, MAD SC Dose 2 - 1200mg ABS201 or Placebo, MAD SC Dose 2 - 600mg ABS201 or Placebo |
Primary outcome
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)
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).
5 secondary outcomes
Pharmacokinetics (PK)
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Pharmacodynamics (PD)
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Immunogenicity
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)
Time frame: Baseline to Week 26
Total Area Hair Width (TAHW) (MAD cohort; participants with AGA)
Time frame: Baseline to week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. The IPD sharing plan is not yet developed. The study team will consider data sharing at a later date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAD IV Dose 1 - 150mg ABS201 IV Single Dose and ABS-201 SC Multiple Doses in people with Androgenetic Alopecia (AGA) and Healthy Volunteers - Male and Female, run by Absci Pty Ltd. at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information Desk (+1 360.949.1041, clinicaltrialinfo@absci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.