Healthy Adult Participants
Conditions
Keywords
Navenibart, STAR-0215
Brief summary
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.
Interventions
COMBINATION_PRODUCTAutoinjector
Navenibart administered subcutaneously via autoinjector
DRUGVial and syringe
Navenibart administered subcutaneously via vial and syringe
Sponsors
Astria Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration (Cmax) following a single dose of subcutaneous navenibart | Up to 84 days post dose | 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 | Up to 84 days post dose | Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach maximum plasma concentration (Tmax) following a single dose of subcutaneous navenibart | Up to 140 days post dose | 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 | Up to 140 days post dose | 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 | Up to 140 days post dose | 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 | Up to 140 days post dose | Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis. |
| Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart | Up to 168 days post dose | Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 28.0 or higher. All AEs will be assigned a severity grade using CTCAE Version 6.0 or higher. Relationship to navenibart will be assessed by the investigator. |
| Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA) | Up to 140 days post dose | ADA will be assessed via a validated bioanalytical method. Incidence will be assessed as proportion of participants with a treatment-emergent ADA. Magnitude of ADA response will be assessed via titers for confirmed ADA-positive samples. |
Countries
United States
Contacts
CONTACTAstria Medical Affairs
Outcome results
None listed