To investigate the safety and tolerability of Aztreonam-Avibactam (ATM-AVI)

Study identifier:D4910C00001

ClinicalTrials.gov identifier:NCT01689207

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam given Alone and in Combination (ATM-AVI)

Medical condition

Complicated Infection

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Avibactam (AVI), Aztreonam (ATM), combination of Aztreonam - Avibactam (ATM-AVI), Placebo

Sex

All

Actual Enrollment

222

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Sept 2012
Primary Completion Date: 01 Dec 2014
Study Completion Date: 01 Dec 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Aug 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria