Phase 1 Study of Single Oral Doses of TIX100 for Safety and Pharmacokinetics in Healthy Adults Aged 18 to 70

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes TIX100, an oral drug that inhibits thioredoxin-interacting protein, in healthy adults aged 18 to 70. This Phase 1, randomized, placebo-controlled study aims to understand how different doses of TIX100 affect healthy participants. The study is sponsored by TIXiMED, Inc. and is conducted at a single center. Participants will receive a single oral dose of TIX100 at varying amounts 20 mg, 60 mg, 100 mg, 160 mg, or 200 mg or a placebo. The study uses a randomized and quadruple-blind design to compare these groups. The intervention is a one-time administration, and participants are closely monitored afterward for safety and drug behavior in the body. During the study, participants undergo assessments including medical exams, vital sign checks, laboratory tests, ECGs, and physical examinations to monitor for any treatment-related side effects and clinically important changes. These evaluations are done up to 7 days post-dose. The study includes careful observation of adverse events and laboratory results to ensure participant safety over the follow-up period, which concludes by May 2025.

A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects