Phase 1 Study Comparing Navenibart by Vial and Syringe Versus Autoinjector in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are comparing two different ways of giving the drug navenibart to healthy adults aged 18 to 55. The study aims to find out if receiving navenibart by vial and syringe or by autoinjector leads to similar drug levels in the blood and similar safety and tolerability profiles. This trial is in Phase 1 and focuses on healthy volunteers to evaluate these two presentations of the drug. Participants will receive a single dose of navenibart either through a vial and syringe or an autoinjector. They will stay in the clinic starting one day before the dose until two days after dosing. After this, participants will return for about nine additional visits that do not require staying overnight. The study compares how the body processes the drug and monitors safety across these two delivery methods. During the study, participants will undergo medical tests including blood draws to measure drug concentrations and monitor for any adverse effects. Researchers will track multiple outcomes such as maximum drug concentration, drug clearance, and the presence of any anti-drug antibodies over several weeks. The total monitoring period extends up to 168 days after dosing to ensure thorough safety and pharmacokinetic assessments.

A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants