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

A Phase 1, Randomized, Open-Label, Parallel-Group Trial Comparing the Pharmacokinetics of Navenibart Administered by Vial/Syringe Versus Autoinjector in Healthy Adult Volunteers

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 Overview

• Status: Recruiting
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: Vial and syringe; Combination product: Autoinjector

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Astria Medical Affairs; Phone Number: 919-859-1302; Email: clinicaltrials@biocryst.com

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Recruiting
      • Fortrea Clinical Trials
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Fortrea Clinical Trials
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Recruiting
      • Fortrea Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Navenibart vial and syringe	Drug: Vial and syringe; Navenibart administered subcutaneously via vial and syringe
Experimental: Navenibart autoinjector	Combination product: Autoinjector; Navenibart administered subcutaneously via autoinjector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach maximum plasma concentration (Tmax) 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 140 days post dose
Apparent clearance (CL/F) 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 140 days post dose
Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart	Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.	Up to 140 days post dose
Terminal half-life (t1/2) following a single subcutaneous dose of navenibart	Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.	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	Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 28.0 or higher. All AEs will be assigned a severity grade using CTCAE Version 6.0 or higher. Relationship to navenibart will be assessed by the investigator.	Up to 168 days post dose
Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA)	ADA will be assessed via a validated bioanalytical method. Incidence will be assessed as proportion of participants with a treatment-emergent ADA. Magnitude of ADA response will be assessed via titers for confirmed ADA-positive samples.	Up to 140 days post dose

Collaborators and Investigators

• Sponsor: Astria Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Navenibart; STAR-0215
• Additional Relevant MeSH Terms: Equipment and Supplies; Syringes
• Other Study ID Numbers: STAR-0215-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes