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NCT04951505 · ClinicalTrials.gov registry record · Phase 1
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
A Phase 1 study, sponsored by Venatorx Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04951505 is a Phase 1 study that has completed, run by Venatorx Pharmaceuticals. The registered enrollment target is 30 participants.
The verdict
NCT04951505, a Phase 1 study, has completed, sponsored by Venatorx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG cefepime-taniborbactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2021-09-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04951505
The ClinicalTrials.gov registry entry for NCT04951505 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Venatorx Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which cefepime-taniborbactam is the first listed.
NCT04951505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04951505 about?
NCT04951505 is a clinical study titled "Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects". 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 intrave...
What is the current status of trial NCT04951505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-06-29. Estimated completion is 2021-09-27.
What interventions are being tested in trial NCT04951505?
The interventions under investigation include: cefepime-taniborbactam (DRUG).
Who is sponsoring clinical trial NCT04951505?
This trial is sponsored by Venatorx Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
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