Clinical Trial

A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated November 25, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants with Renal Impairment
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-07-29; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2025-09-17
Trial Details
NCT Number NCT07104162
Lead Sponsor Qpex Biopharma, Inc.
Collaborators: Shionogi Inc., Biomedical Advanced Research and Development Authority
Conditions Bacterial Infections
Enrollment 40 participants
Start Date 2025-09-16
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-12-23 (estimated)
Updated on ClinicalTrials.gov 2025-11-25