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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
227
ABS-201 is an IgG1 monoclonal antibody developed to specifically target the prolactin receptor (PRLR),
Matching placebo
Multiple doses of ABS-201 for Subcutaneous injection
Subcutaneous Placebo injection for MAD arms
Sinclair Dermatology
Melbourne, Victoria, Australia
NOT_YET_RECRUITINGNucleus Network
Melbourne, Victoria, Australia
RECRUITINGIncidence 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)
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)
Terminal elimination Half-life
The time required for the terminal phase blood concentration to decrease by half
Time frame: From enrollment to the end of the Study (SAD up to 12 months, MAD up to 18 months)
Change from Baseline in Prolactin
Change from baseline in PRL levels,
Time frame: Enrollment up to End of Study (SAD up to 12 months, MAD up to 18 months)
Change from Baseline in DHEA-S
Change from baseline in dehydroepiandrosterone (DHEA-S)
Time frame: Enrollment up to End of Study (SAD 12months or MAD 18 months)
Change from Baseline in IGF-1
Change from Baseline in Insulin Growth Factor
Time frame: Enrollment up to the end of study (SAD 12 months or MAD 18 months)
Treatment Emergent Incidence of ADA
Measuring Incidence of Anti-Drug Affects (ADAs)
Time frame: Enrollment up to End of Study (SAD 12 months or MAD 18 months)
Treatment Emergent Incidence of NAb
Measure the treatment emergent incidence of Neutralizing Antibodies (NAbs) in participants who have developed ADAs
Time frame: Enrollment up to the End of Study (SAD 12 months, MAD 18 months)
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