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

NCT07635095 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: STAR-0215-102
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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

Keywords

Navenibart; STAR-0215

Outcome Measures

Primary Outcomes (2)

• Maximum concentration (Cmax) following a single dose of subcutaneous navenibart

  Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.

  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

  Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.

  Up to 84 days post dose

Secondary Outcomes (6)

• Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart

  Up to 140 days post dose

• Apparent clearance (CL/F) following a single dose of subcutaneous navenibart

  Up to 140 days post dose

• Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart

  Up to 140 days post dose

• Terminal half-life (t1/2) following a single subcutaneous dose of navenibart

  Up to 140 days post dose

• Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart

  Up to 168 days post dose

Study Arms (2)

Navenibart vial and syringe

ACTIVE COMPARATOR

Drug: Vial and syringe

Navenibart autoinjector

EXPERIMENTAL

Combination Product: Autoinjector

Interventions

Autoinjector COMBINATION_PRODUCT

Navenibart administered subcutaneously via autoinjector

Navenibart autoinjector

Vial and syringe DRUG

Navenibart administered subcutaneously via vial and syringe

Navenibart vial and syringe

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astria Therapeutics, Inc.: lead

Study Sites (3)

Fortrea Clinical Trials

Daytona Beach, Florida, 32117, United States

RECRUITING

Fortrea Clinical Trials

Dallas, Texas, 75247, United States

RECRUITING

Fortrea Clinical Trials

Madison, Wisconsin, 53704, United States

RECRUITING

MeSH Terms

Interventions

Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Astria Medical Affairs

CONTACT

919-859-1302; clinicaltrials@biocryst.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: June 9, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)