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Bioanalytical Assay Comparison for Tebipenem
NCT05856747Phase 1Completed
- Sponsor
- Spero Therapeutics
- Start
- May 2023
- Primary completion
- Jun 2023
- Modality
- Drug Delivery Systems
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of tebipenem in complicated urinary tract infection (cUTI) and acute pyelonephritis, sponsored by Spero Therapeutics. Primary endpoints: Percentage of Tebipenem (TBP) Samples With Converted (From Whole Blood Measurements) and Measured Plasma Concentrations That Have a Difference not Exceeding ±20% of the Mean of the Concentrations at Day 1, Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-∞) of TBP at Day 1 and 1 more. Started May 2023; status: completed.
02
Drugs
tebipenem
03
Conditions
complicated urinary tract infection (cUTI)acute pyelonephritis
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