Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Healthy 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

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

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

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

Design model

Sequential

Treatments tested in this trial

ABS-201 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

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

Incidence rate of treatment-related adverse events

Safety assessments based on reporting of Treatment Emergent Adverse Events

Time frame

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

Secondary outcomes

CMAX

Peak concentration: The highest blood concentration after study drug administration

Time frame

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

AUC

Area under the drug time curve: The area surrounded by the blood concentration curve to the time axis.

Time frame

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

TMAX

Peak time: The time required to reach peak concentration after study drug administration

Time frame

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

Terminal elimination rate

The terminal elimination rate constant is obtained from the linear regression of the phase elimination concentration point

Time frame

Enrollment up to the End of Study (SAD up to 12 months, MAD up to 18 months)

Other outcomes

Change from Baseline in Total Area Hair Count (TAHC)

Measures the change from baseline in Total Area Hair Count (TAHC) in healthy adult participants with AGA.

Time frame

Enrollment and up to End of Study Visit (SAD 12 months, MAD 18 months)

Change from Baseline in Total Area Hair Width (TAHW)

Change from baseline in Total Area Hair Width (TAHW) in healthy adult participants with AGA.

Time frame

Enrollment to the End of Study (SAD 12 months, MAD 18 months)

Change From baseline Participant Self Assessment of Hair Growth

Hair Growth Assessment in participants with AGA using central photography images comparing baseline to later visits using a Subject Self-Assessment Scale. This scale is an ordinal scale with 7 options (Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). Improved scores suggest improved hair growth.

Time frame

Enrollment up to End of Study (SAD 12 months, MAD 18 months)

Change From baseline Investigator Global Assessment of Hair Growth

Change from baseline in central photography images comparing baseline to later visits using an Investigator Global Assessment Scale. This scale is an ordinal scale with 7 options (Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). Improved scores suggest improved hair growth.

Time frame

Enrollment to End of Study (SAD 12 months, MAD 18 months)

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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