A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers

Phase 1 Completed 46 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the combination of RO7079901 with meropenem in healthy volunteers. The study will consist of three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers will be randomized to receive active study drug or placebo in a 3:1 ratio.

Timeline

Start: 2016-10-31
Primary completion: 2017-03-24
Completion: 2017-03-24

Publications

Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Meropenem	Small molecule	2000 mg	Intravenous
Subject	nacubactam	Small molecule	1000 mg	Intravenous
Subject	nacubactam	Small molecule	2000 mg	Intravenous

Indications

No indication recorded.