Randomized Placebo-Controlled Study Evaluating Safety and Pharmacokinetics of Oral TIX100 in Healthy Overweight Adults Aged 18 to 70

What this Trial Is About

Researchers are conducting a randomized, placebo-controlled Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of the oral drug TIX100 in healthy overweight or obese adults aged 18 to 70 years. The study focuses on otherwise healthy adults with a body mass index between 25 and 34.9 kgm2, aiming to assess how the drug behaves in the body and its safety profile over a 28-day treatment period. Participants are assigned randomly to one of four groups receiving different doses of TIX100 40 mg, 80 mg, or 120 mg twice daily or a placebo, all administered orally daily for 28 days. This study uses a quadruple masking design to ensure unbiased results. The primary purpose is treatment evaluation, and the study is sponsored by TIXiMED, Inc. During the study, participants will undergo safety and tolerability assessments from Day 1 to Day 35. Pharmacokinetic measurements, including the area under the concentration curve, will be taken on Days 1 and 28. Subjects will be monitored with medical examinations, vital signs, laboratory tests, cardiac and respiratory function assessments, and adherence to protocol. Participation is expected to last from the start date in June 2026 through December 2026, with the primary outcome data collected by October 2026.

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