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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Astria Therapeutics, Inc.
Study ID
NCT07635095
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Autoinjector — COMBINATION_PRODUCT
    Navenibart administered subcutaneously via autoinjector
  • Vial and syringe — DRUG
    Navenibart administered subcutaneously via vial and syringe

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Navenibart vial and syringe
  • Experimental: Navenibart autoinjector

Primary Outcome Measure

Maximum concentration (Cmax) following a single dose of subcutaneous navenibart [ Time Frame: Up to 84 days post dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Fortrea Clinical TrialsDaytona BeachFlorida32117-
Fortrea Clinical TrialsDallasTexas75247-
Fortrea Clinical TrialsMadisonWisconsin53704-

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By research site
Fortrea Clinical Trials· Daytona Beach, FLFortrea Clinical Trials· Dallas, TXFortrea Clinical Trials· Madison, WI

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