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NCT07635095

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

Recruiting
PHASE1Ages 18–55Interventional
Astria Therapeutics, Inc.
~180 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:AutoinjectorVial and syringe

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum concentration (Cmax) following a single dose of subcutaneous navenibart
Measured over Up to 84 days post dose
+1 more outcome measured

Conditions

Healthy Adult Participants

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Healthy Volunteers

NCT07635095

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fortrea Clinical Trials

    Daytona Beach, Floridano site contact published

    Recruiting

  • Fortrea Clinical Trials

    Dallas, Texasno site contact published

    Recruiting

  • Fortrea Clinical Trials

    Madison, Wisconsinno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Astria Medical Affairs
[email protected]
919-859-1302
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Maximum concentration (Cmax) following a single dose of subcutaneous navenibartUp to 84 days post dose

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

  • Area under the concentration versus time curve from time 0 to 84 days (AUC0-84d) following a single dose of subcutaneous navenibartUp to 84 days post dose

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