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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstria Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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/m²

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Autoinjector
  • Vial and syringe

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators