Phase 1 Study to Assess Safety and Tolerability of IMP761, an Immunosuppressive Antibody, in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new immunosuppressive antibody called IMP761 in healthy adult volunteers aged 18 to 55 years. This first-in-human, randomized, double-blind, placebo-controlled trial aims to determine if single and multiple doses of IMP761 are safe by monitoring vital signs, adverse events, electrocardiography, and laboratory tests. Part B also explores how IMP761 affects the immune response triggered by keyhole limpet haemocyanin KLH. The study consists of three parts Part A and B involve single ascending doses of IMP761 or placebo given intravenously, with Part B including KLH immunization and challenge. Part C involves multiple intravenous doses administered every 28 days for three doses. Participants will receive either IMP761 or a matching placebo during a 4-day in-clinic stay followed by several follow-up visits. The dose and schedule depend on findings from earlier parts of the study. Participants will be closely monitored throughout the study, which lasts up to 103 days from the first dose. Assessments include vital signs, adverse event tracking, electrocardiograms, clinical laboratory tests, laser speckle contrast imaging, and multispectral skin imaging. Researchers will measure pharmacokinetics and pharmacodynamics, and monitor safety laboratory results. The study includes detailed follow-up visits to evaluate any safety concerns and immune responses.

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers