Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy Adults With and Without Androgenetic Alopecia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbsci Pty Ltd.
About this trial
The goal of this clinical trial is to learn if ABS-201 (a new medication) is safe and tolerable when used to improve hair growth in men and women. The trial will start with healthy volunteers and if safe, will treat participants with certain types of hair loss.
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 1 year.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- ABS-201 IV Single Dose
- Placebo IV
- ABS-201 SC Multiple Doses
- Placebo SC Injection
Treatment groups
227 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov