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RECRUITING
NCT07635095
PHASE1

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

Sponsor: Astria Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

Autoinjector

Navenibart administered subcutaneously via autoinjector

DRUG

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