Navenibart: comparing vial-and-syringe vs autoinjector in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial compares two presentations of navenibart in healthy adults to see if they achieve similar pharmacokinetics and safety. Participants are randomized to receive a single dose via either the vial-and-syringe or the autoinjector and stay in the clinic from the day before dosing through several days after. The study involves scheduled blood draws and other safety assessments across about 11 visits, with data used to compare drug exposure and tolerability between the two formats. The trial is sponsored by Astria Therapeutics and conducted at Fortrea Clinical Trials sites in Florida, Texas, and Wisconsin.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Astria Medical Affairs
• Email: clinicaltrials@biocryst.com
• Phone: 919-859-1302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.