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Recruiting Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT07635095

Public ClinicalTrials.gov record NCT07635095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07635095
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Astria Therapeutics, Inc.
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

Combination Product · Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 20, 2026
Primary completion
Aug 31, 2026
Completion
Nov 30, 2026
Last update posted
Jun 8, 2026

2026

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Fortrea Clinical Trials Daytona Beach Florida 32117 Recruiting
Fortrea Clinical Trials Dallas Texas 75247 Recruiting
Fortrea Clinical Trials Madison Wisconsin 53704 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07635095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 8, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07635095 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →