Study identifier:D4910C00001
ClinicalTrials.gov identifier:NCT01689207
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Complicated Infection
Phase 1
Yes
Avibactam (AVI), Aztreonam (ATM), combination of Aztreonam - Avibactam (ATM-AVI), Placebo
All
222
Interventional
18 Years - 150 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Aug 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Drug: A Avibactam (AVI) | Drug: Avibactam (AVI) PART A: AVI IV infusion |
Experimental: Drug: B Aztreonam (ATM) | Drug: Aztreonam (ATM) PART A: ATM IV infusion |
Experimental: Drug: C combination of Aztreonam-Avibactam (ATM-AVI) | Drug: combination of Aztreonam - Avibactam (ATM-AVI) PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions. |
Placebo Comparator: Drug: D Matching Placebo | Drug: Placebo PART A, PART B, PART C: matching placebo IV infusions |