Randomized Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral TIX100 in Healthy Overweight Adults

What This Trial Is About

Researchers are evaluating the safety and tolerability of multiple oral doses of TIX100 given daily for 28 days in otherwise healthy adults who are overweight or obese. This Phase 1 randomized, placebo-controlled study aims to better understand how the body processes TIX100 and how well it is tolerated in this population. Participants are randomly assigned to one of four groups receiving either TIX100 at doses of 40 mg, 80 mg, or 120 mg twice daily, or a placebo, all administered orally for 28 days. The study uses a sequential design with quadruple masking to compare safety, tolerability, and pharmacokinetics across these dosing regimens. During the study, participants will undergo medical evaluations including history, physical exams, vital signs, laboratory tests, cardiac monitoring, and respiratory assessments to monitor safety and tolerability over 35 days. Researchers will also measure drug concentration levels on Days 1 and 28 to assess pharmacokinetics. The total study duration spans from June to December 2026.

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects