Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
Status:
Not yet recruiting
Trial end date:
2023-11-13
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)