Recruiting
Phase 1

Navenibart vs. Navenibart

Sponsor:

Astria Therapeutics, Inc.

Code:

NCT07635095

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Autoinjector

Vial and syringe

Study Details

Brief 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

Study ID

NCT07635095

Start date

Apr 21, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Key Inclusion Criteria:

  • Males and females 18 to 55 years of age
  • In good health, as determined by the Investigator
  • Written informed consent, including confirmation of willingness to comply with all trial procedures
  • Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg/m\^2
  • Has not previously received navenibart
  • Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods.

Key Exclusion Criteria:

  • Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial.
  • Key laboratory results outside of defined ranges
  • History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse
  • Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing
  • History of severe allergic reactions with an unknown cause
  • Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing.
  • Known hypersensitivity to any component of navenibart
  • Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Navenibart vial and syringe

experimental: Navenibart autoinjector

Interventions

Autoinjector

Navenibart administered subcutaneously via autoinjector

Vial and syringe

Navenibart administered subcutaneously via vial and syringe

Primary outcome measure

  • Maximum concentration (Cmax) following a single dose of subcutaneous navenibart [ Time Frame: Up to 84 days post dose ]
  • Area under the concentration versus time curve from time 0 to 84 days (AUC0-84d) following a single dose of subcutaneous navenibart [ Time Frame: Up to 84 days post dose ]

Central Contacts and Locations

Central contacts

Astria Medical Affairs

919-859-1302clinicaltrials@biocryst.com

Locations

Fortrea Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117

Fortrea Clinical Trials

Recruiting

Dallas, Texas, United States, 75247

Fortrea Clinical Trials

Recruiting

Madison, Wisconsin, United States, 53704

More Information

Sponsor

Astria Therapeutics, Inc.

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Navenibart
  • STAR-0215

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Astria Therapeutics, Inc. on 2026-06-09.