Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare the drug concentrations and safety profile of each group to determine if they are similar.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navenibart vial and syringe | Active Comparator |
| |
| Navenibart autoinjector | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autoinjector | Combination Product | Navenibart administered subcutaneously via autoinjector |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 84 days post dose |
| 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. | Up to 84 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 140 days post dose |
| Apparent clearance (CL/F) following a single dose of subcutaneous navenibart |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astria Medical Affairs | Contact | 919-859-1302 | clinicaltrials@biocryst.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Trials | Recruiting | Daytona Beach | Florida | 32117 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vial and syringe | Drug | Navenibart administered subcutaneously via vial and syringe |
|
Plasma concentrations are assessed via a validated method and used to estimate PK parameters via noncompartmental analysis. |
| Up to 140 days post dose |
| 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. | Up to 140 days post dose |
| 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. | Up to 140 days post dose |
| Incidence of treatment-emergent adverse events (TEAEs), including severity and relationship to navenibart following a single subcutaneous dose of navenibart | 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. | Up to 168 days post dose |
| Incidence and magnitude of treatment-emergent anti-drug antibodies (ADA) | 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. | Up to 140 days post dose |
| Fortrea Clinical Trials |
| Recruiting |
| Dallas |
| Texas |
| 75247 |
| United States |
| Fortrea Clinical Trials | Recruiting | Madison | Wisconsin | 53704 | United States |