Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia

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
• Must have a body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening, with a total body weight >60 kg.
• 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
• Additional Inclusion Criteria for postmenopausal women with AGA: Diagnosis of AGA with a Ludwig Scale I-3, I-4, II-1, II-2 pattern, with a documented history of AGA for ≥12 months and no rapid progression (e.g., sudden shedding, acute diffuse thinning, or scarring alopecia) in the 6 months prior to screening.

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:

• 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