Phase 1 Study to Assess the Safety, Tolerability, and Body Processing of LWP779 in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and active metabolites of the drug LWP779 after oral administration in healthy adults. This Phase 1 study includes single ascending dose SAD, food effect, and multiple ascending dose MAD phases to understand how the drug behaves in the body and its safety profile. The study involves administering LWP779 or a placebo to healthy participants in varying doses during different phases. The SAD phase tests increasing single doses, the food effect phase examines the impact of eating on drug absorption, and the MAD phase assesses multiple doses over time. Participants receive oral doses under controlled conditions, including a high-fat meal during the food effect phase, with careful monitoring throughout each phase. Participants will be involved in medical history reviews, physical exams, vital sign checks, laboratory tests, 12-lead ECGs, and suicide severity ratings to monitor safety from baseline through days 7 to 16 depending on the phase. Researchers will measure adverse events, vital sign changes, ECG results, and laboratory abnormalities to assess tolerability. The trial runs from screening through the treatment phases, with detailed pharmacokinetic sampling to track how LWP779 and its metabolites are processed in the body.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants