NCT02674347

MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

Detailed description

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts. Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects. Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	3 g or 6 g Zidebactam	IV for over a duration of 60 minutes
DRUG	Placebo	IV matching the Investigational drug

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-02-04
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States