Phase I Study to Evaluate Safety, Tolerability, and Effects of Single and Multiple Doses of BAR502 in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting a first-in-human Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAR502 in healthy adults aged 18 to 55 years. This study includes two parts Part A is a randomized, double-blind, placebo-controlled trial with single ascending doses, while Part B is an open-label study with multiple ascending doses based on safety information from Part A. The study is designed to understand how BAR502 behaves in the body and its effects at different doses. In Part A, participants will receive a single oral dose of BAR502 or a matching placebo in one of four dose levels. Part B involves two cohorts receiving multiple daily doses of BAR502 for 14 days, with dose levels chosen from Part As results. BAR502 tablets will be taken in the morning after fasting, and placebo tablets will be given similarly in Part A. The study uses a dose-escalation approach to assess increasing doses safely. Participants will be monitored closely with assessments including vital signs, physical exams, laboratory tests, and electrocardiograms. Blood and urine samples will be collected at specified time points to measure drug levels and biomarkers. Safety will be tracked through adverse event reporting and changes in heart rate, blood pressure, and liver function tests. The study duration includes dosing days and follow-up visits up to Day 30 to ensure thorough evaluation of safety and drug effects.

To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects