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

NCT07635095 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

  • Healthy Adult Participants

Interventions

COMBINATION_PRODUCT

Autoinjector

Navenibart administered subcutaneously via autoinjector

DRUG

Vial and syringe

Navenibart administered subcutaneously via vial and syringe

Sponsors & Collaborators

  • Astria Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635095 on ClinicalTrials.gov