Phase 1 Study to Assess Safety, Immune Effects, and Drug Levels of PVT401 in Healthy Adults with Single and Multiple IV Doses

What this Trial Is About

Researchers are studying how PVT401, a drug designed for inflammatory bowel disease IBD, behaves in the body and affects the immune system. This Phase 1 trial mainly focuses on understanding the safety and side effects of single and multiple intravenous doses of PVT401 in healthy adults aged 18 to 65. The study aims to find out how long the drug stays in the body and if any adverse events occur. The trial includes two phases a Single Ascending Dose SAD phase and a Multiple Ascending Dose MAD phase. In the SAD phase, participants stay in the clinic for two nights, receive one intravenous dose of either PVT401 or placebo, and have blood samples taken over several visits up to four weeks after dosing. In the MAD phase, participants receive doses twice weekly for five weeks, staying overnight at the clinic before each dose, with follow-up visits extending up to six months after the last dose. Placebo groups receive normal saline matching the PVT401 dosing schedule. Participants will undergo various assessments including blood draws, vital sign monitoring, and safety evaluations during and after dosing. Researchers will measure laboratory parameters, electrocardiograms, and pharmacokinetics to evaluate the drugs safety and how it is processed in the body. The study involves regular clinic visits for treatment and follow-up to monitor any side effects and ensure participant safety throughout the trial period.

A Phase 1 Study of PVT401 in Healthy Subjects