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NCT05645757 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT05645757 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 54 participants.
The verdict
NCT05645757, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years old (both inclusive). Seven treatment cohorts will be evaluated in this study. WCK 6777 will be evaluated in three cohorts - Cohorts 1, 4 and 7- of 8 subjects each (6 study drug combinations and 2 placebos); ERT will be evaluated alone in two cohorts - Cohorts 2 and 5- of 8 subject each (6 ERT and 2 placebos); and ZID will be evaluated in two cohorts, Cohorts 3 and 6, of 6 subjects each (all ZID). The study will be placebo-controlled and double-blinded in all cohorts except Cohorts 3 and 6. No placebo subjects are included in standalone ZID cohorts, since adequate safety data for higher doses of ZID alone in comparison with placebo are available from completed Phase 1 studies of WCK 5107 (ZID) alone and the ZID-only arms of WCK 5222 (cefepime + ZID) studies. The primary objective is to assess the safety and tolerability of three dose-escalating regimens of WCK 6777 ( ERT and ZID combination) and two-dose escalating regimens of standalone ERT or ZID following single daily doses for 7 days in healthy adult subjects.
Interventions
- OTHER Placebo
- DRUG Ertapenem
- DRUG WCK 6777
- DRUG Zidebactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2023-11-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05645757
The ClinicalTrials.gov registry entry for NCT05645757 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05645757 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05645757 about?
NCT05645757 is a clinical study titled "Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)". This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years...
What is the current status of trial NCT05645757?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2023-04-19. Estimated completion is 2023-11-03.
What interventions are being tested in trial NCT05645757?
The interventions under investigation include: Placebo (OTHER), Ertapenem (DRUG), WCK 6777 (DRUG), Zidebactam (DRUG).
Who is sponsoring clinical trial NCT05645757?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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