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

ConditionsAndrogenetic Alopecia (AGA)Healthy Volunteers - Male and Female
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbsci Pty Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

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

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

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

Design model

Sequential

Treatments tested in this trial

  • SAD IV Dose 1 - 150mg ABS201 IV Single Dose

    Drug

    ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR)

  • Placebo IV

    Drug

    Matching placebo

  • ABS-201 SC Multiple Doses

    Drug

    Multiple doses of ABS-201 for Subcutaneous injection

  • Placebo SC Injection

    Drug

    Subcutaneous Placebo injection for MAD arms

Treatment groups

227 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: SAD IV Dose 1 - 150mg ABS201 or PlaceboExperimental treatment 2 interventions
Group B: SAD IV Dose 2 - 450mg ABS201 or PlaceboExperimental treatment 2 interventions
Group C: SAD IV Dose 3 - 900mg ABS201 or PlaceboExperimental treatment 2 interventions
Group D: SAD IV Dose 4 - 1800mg ABS201 or PlaceboExperimental treatment 2 interventions
Group E: MAD SC Dose 1 - 300mg ABS201 or PlaceboExperimental treatment 2 interventions
Group F: MAD SC Dose 2 - 600mg ABS201 or PlaceboExperimental treatment 2 interventions
Group G: MAD SC Dose 2 - 1200mg ABS201 or PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence rate of treatment-emergent adverse events (TEAEs) and serious TEAEs

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).

Time frame
From enrollment to the end of the Study (SAD approximately 12 months, MAD approximately 18 months)

Secondary outcomes

1

Pharmacokinetics (PK)

To investigate the pharmacokinetics (PK) characteristic of ABS201, Serum trough concentrations at each time point and descriptive statistics.

Time frame
From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
2

Pharmacodynamics (PD)

Change from baseline in prolactin (PRL).

Time frame
From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
3

Immunogenicity

Incidence of anti-drug antibodies (ADAs) and, in participants who develop ADAs, neutralizing antibodies (NAbs).

Time frame
From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
4

Target Area Hair Count (TAHC) (MAD; participants with AGA)

Change from baseline in Total Area Hair Count (TAHC)

Time frame
Baseline to Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Absci Pty Ltd.

Lead sponsor

Source ClinicalTrials.gov
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