Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Conditions
Keywords
Androgenetic Alopecia, Hair Loss, AGA, Female hair loss, Male pattern baldness, hair regrowth
Brief 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. 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.
Interventions
DRUGSAD IV Dose 1 - 150mg ABS201 IV Single Dose
ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR)
DRUGPlacebo IV
Matching placebo
DRUGABS-201 SC Multiple Doses
Multiple doses of ABS-201 for Subcutaneous injection
Subcutaneous Placebo injection for MAD arms
Sponsors
Absci Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) | From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months) | To investigate the pharmacokinetics (PK) characteristic of ABS201, Serum trough concentrations at each time point and descriptive statistics. |
| Pharmacodynamics (PD) | From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months) | Change from baseline in prolactin (PRL). |
| Immunogenicity | From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months) | Incidence of anti-drug antibodies (ADAs) and, in participants who develop ADAs, neutralizing antibodies (NAbs). |
| Target Area Hair Count (TAHC) (MAD; participants with AGA) | Baseline to Week 26 | Change from baseline in Total Area Hair Count (TAHC) |
| Total Area Hair Width (TAHW) (MAD cohort; participants with AGA) | Baseline to week 26 | Change from baseline in Total Area Hair Width (TAHW) |
Countries
Australia
Contacts
CONTACTClinical Trial Information Desk
Outcome results
None listed