Phase 1 Study to Evaluate Empasiprubart Given by Autoinjector or Intravenous Infusion in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating how the body responds to empasiprubart when given using an autoinjector AI. This study focuses on understanding the effects, how empasiprubart works in the body, and its safety. The study involves healthy adult volunteers aged 18 to 65 and is sponsored by argenx. The study has two parts, A and B. In part A, participants are randomly assigned to receive empasiprubart as a subcutaneous injection via autoinjector in the abdomen, via autoinjector in the thigh, or as an intravenous infusion. In part B, participants are randomized to receive empasiprubart either by subcutaneous autoinjector in the abdomen or by intravenous infusion. The treatment periods last up to 37 weeks for part A and up to 43 weeks for part B. During the study, participants will undergo various assessments to monitor drug levels, body response, and safety. Researchers will measure how empasiprubart is absorbed and processed in the body, including specific outcomes such as drug concentration over time and immune responses. Safety will be monitored by tracking any adverse events. Participants will attend regular visits for evaluations throughout the study period.

A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants