Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-09 @ 2:16 PM
Study NCT ID:
NCT04951505
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
Sponsor:
Venatorx Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2025-06
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:
None
Brief Summary:
This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: