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First received: December 01, 2022

Clinical Trial: Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Bacterial Infection

Study Type: INTERVENTIONAL


Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Ertapenem in Combination With Zidebactam (WCK 6

Brief 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…

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