drugset / Trial / NCT07612020

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

NCT07612020

Phase 1 Recruiting 130 enrolled argenx
RandomizedParallel-groupSingle-blindTreatment

Summary

This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe. The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV. Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.

Timeline

Start
2026-03-16
Primary completion
2027-03
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Empasiprubart Monoclonal antibody Subcutaneous

Indications

No indication recorded.