A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

Phase 1/2 Completed 15 enrolled Theriva Biologics, Inc.

NaSingle-groupOpen-labelTreatment

Summary

A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy

Timeline

Start: 2015-06
Primary completion: 2016-04
Completion: 2016-04

Publications

Kokai-Kun JF, Roberts T, Coughlin O, Sicard E, Rufiange M, Fedorak R, Carter C, Adams MH, Longstreth J, Whalen H, Sliman J. The Oral beta-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e02197-16. doi: 10.1128/AAC.02197-16. Print 2017 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftriaxone	Other / unclassified	1 g	Intravenous
Subject	Esomeprazole	Small molecule	40 mg	Oral
Subject	Ribaxamase	Monoclonal antibody	150 mg	Oral

Indications

No indication recorded.