180 Participants NeededMy employer runs this trial

Navenibart Administration Methods for Healthy Adults

Recruiting at 2 trial locations
AM
Overseen ByAstria Medical Affairs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am between 18 and 55 years old.
* 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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one dose of navenibart with either the vial and syringe or the autoinjector

3 days
1 residential visit (3 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
9 non-residential visits

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

Group I: Navenibart autoinjectorExperimental Treatment1 Intervention
Group II: Navenibart vial and syringeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astria Therapeutics, Inc.

Lead Sponsor

Trials
5
Recruited
310+