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

Absci Pty Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Androgenetic Alopecia (AGA); Healthy Volunteers - Male and Female

Treatments: Drug: ABS-201 SC Multiple Doses; Drug: Placebo SC Injection; Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose; Drug: Placebo IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT07317544

ABS-201-101

Details and patient eligibility

About

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.

Enrollment: 227 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

•

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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227 participants in 7 patient groups

SAD IV Dose 1 - 150mg ABS201 or Placebo

Experimental group

Description:

ABS-201 IV Single Dose

Treatment:

Drug: Placebo IV

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose

SAD IV Dose 2 - 450mg ABS201 or Placebo

Experimental group

Description:

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Treatment:

Drug: Placebo IV

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose

SAD IV Dose 3 - 900mg ABS201 or Placebo

Experimental group

Description:

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Treatment:

Drug: Placebo IV

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose

SAD IV Dose 4 - 1800mg ABS201 or Placebo

Experimental group

Description:

Single Intra-venous dose of active study drug or placebo in Healthy Volunteers

Treatment:

Drug: Placebo IV

Drug: SAD IV Dose 1 - 150mg ABS201 IV Single Dose

MAD SC Dose 1 - 300mg ABS201 or Placebo

Experimental group

Description:

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Treatment:

Drug: Placebo SC Injection

Drug: ABS-201 SC Multiple Doses

MAD SC Dose 2 - 600mg ABS201 or Placebo

Experimental group

Description:

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Treatment:

Drug: Placebo SC Injection

Drug: ABS-201 SC Multiple Doses

MAD SC Dose 2 - 1200mg ABS201 or Placebo

Experimental group

Description:

Multiple Ascending Doses of active study drug or placebo delivered subcutaneously in Patients with AGA

Treatment:

Drug: Placebo SC Injection

Drug: ABS-201 SC Multiple Doses