Trial Profile

A Phase 1, Open-label Study to Evaluate the Safety and to Characterize the Pharmacokinetics of a Fixed-Dose Combination Formulation of Ceftibuten-Ledaborbactam Etzadroxil

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 14 Jul 2026

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At a glance

Drugs Amoxicillin/clavulanic acid (Primary) ; Ceftibuten (Primary) ; Ceftibuten/ledaborbactam etzadroxil (Primary) ; Esomeprazole (Primary) ; Ledaborbactam etzadroxil (Primary)
Indications Bacterial infections; Urinary tract infections
Focus Adverse reactions; Pharmacokinetics
Sponsors VenatoRx Pharmaceuticals

Most Recent Events

09 Jul 2026 Arms increased from 4 to 5, with the addition of the Active Comparator: Part 3 Group 3 (amoxicillin-clavulanate).
09 Jul 2026 Planned number of patients changed from 46 to 96.
09 Jul 2026 Planned End Date changed from 30 Jun 2026 to 30 Dec 2026.

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