Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02349802
Brief Summary:
Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector.
Detailed Description:
Phase I multi-cohort study will employ a flexible study design to accommodate multiple cohorts. Healthy male or female subjects \>or= 18 years with no significant health issues will be included. Each cohort will employ an open-label, single-arm, repeat-dose design. Injection failure rates will be continually assessed. Injection pain will also be assessed.
Study:
NCT02349802
Study Brief:
Protocol Section:
NCT02349802