💬In plain words
What the trial is, and whether it could suit you
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 participan
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria (Major):
* 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:
* 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
Exclusion Criteria (Major):
* 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
* 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:
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Prior use of hair loss treatments:
1. Topical minoxidil within 3 months before screening.
2. Oral minoxidil other hair growth stimulators within 6 months before screening.
3. Finasteride within 6 months before screening
4. 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
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