NCT07635095
A Trial to Compare the Pharmacokinetics of Two Presentations of Navenibart in Healthy Participants
Recruiting
PHASE1Ages 18–55InterventionalAstria 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
Where it's being run
3 sites across 3 statesFlorida1
Texas1
Wisconsin1
Who to contact
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Do you actually qualify for this trial?
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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.