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A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
Sponsor: Astria Therapeutics, Inc.
Summary
The goal of this clinical trial is to compare two different presentations (vial and syringe versus autoinjector) of navenibart in healthy adult volunteers. The main questions it aims to answer are: * Do these presentations lead to similar drug concentrations in the blood? * Do these presentations lead to similar safety and tolerability? Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar. Participants will: * Receive one dose of navenibart with either the vial and syringe or the autoinjector. * Stay in the clinic beginning one day prior to dosing through 2 days after dosing. * Return to the clinic for approximately 9 additional non-residential visits. * Complete medical and other testing, including blood draws.
Official title: A Phase 1, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial/Syringe Versus Autoinjector in Healthy Adult Volunteers
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-04-21
Completion Date
2026-12
Last Updated
2026-06-09
Healthy Volunteers
Yes
Conditions
Interventions
Autoinjector
Navenibart administered subcutaneously via autoinjector
Vial and syringe
Navenibart administered subcutaneously via vial and syringe
Locations (3)
Fortrea Clinical Trials
Daytona Beach, Florida, United States
Fortrea Clinical Trials
Dallas, Texas, United States
Fortrea Clinical Trials
Madison, Wisconsin, United States