Study to Evaluate Safety and Effects of ABS-201 Medication in Healthy Adults and Adults with Androgenetic Alopecia Phase 1 and 2 Trial Comparing Single and Multiple Doses of ABS-201 with Placebo

What this Trial Is About

Researchers are evaluating ABS-201, a new medication designed to target the prolactin receptor, to see if it is safe and tolerable for improving hair growth in men and women. This trial includes healthy volunteers and participants with androgenetic alopecia AGA, a common form of hair loss. The study aims to compare ABS-201 with a placebo to identify any medical problems caused by single or multiple doses of the drug. Participants will receive either a single intravenous dose or multiple subcutaneous doses of ABS-201 or placebo. The single-dose phase involves healthy volunteers receiving one of several intravenous doses ranging from 150mg to 1800mg. The multiple-dose phase includes patients with AGA receiving ascending subcutaneous doses from 300mg up to 1200mg. These treatments are given at scheduled times, and the trial is randomized and double-blind to ensure unbiased results. During the trial, participants will visit the study clinic for regular checkups, tests, and monitoring over approximately 12 to 18 months depending on the dosing phase. Researchers will track treatment-related adverse events, pharmacokinetics, and changes in hormone levels such as prolactin and IGF-1. These evaluations include blood tests, physical exams, and hair assessments. The study will also monitor immune responses and collect safety data throughout the trial period.

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