Navenibart Administration Methods for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for healthy men and women aged 18 to 55, with a body weight between 50 and 100 kg and BMI between 18 and 30. Participants must not be pregnant or breastfeeding, must never have received navenibart before, and need to agree to follow all study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one dose of navenibart with either the vial and syringe or the autoinjector
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares how the body processes one dose of navenibart given by either an autoinjector or a vial and syringe in healthy adults. Participants are randomly assigned to receive the drug using one method.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astria Therapeutics, Inc.
Lead Sponsor
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