Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-22 @ 12:22 PM
Study NCT ID:
NCT02349802
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2015-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoinjector Device Assessment Study
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Evaluation of the Single-Use Pre-Filled Autoinjector
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCB119
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: