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.
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
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
Parallel
Autoinjector
Combination productNavenibart administered subcutaneously via autoinjector
Vial and syringe
DrugNavenibart administered subcutaneously via vial and syringe
Maximum concentration (Cmax) following a single dose of subcutaneous navenibart
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 navenibart
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Apparent clearance (CL/F) following a single dose of subcutaneous navenibart
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Apparent volume of distribution during the terminal phase (Vz/F) following a single subcutaneous dose of navenibart
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Terminal half-life (t1/2) following a single subcutaneous dose of navenibart
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis.
Click on the lead sponsor to view all of their trials.
