Conditions: Complicated Infection Bacterial Infections
Keywords: Phase I, Safety, tolerability, healthy.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: yes

Brief summary:
This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple administrations of ATM-AVI in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

Detailed description:
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)

Arms:
arm 1: Avibactam (AVI) arm 2: Aztreonam (ATM) arm 3: combination of Aztreonam-Avibactam (ATM-AVI) arm 4: Matching Placebo

Interventions: intervention 1: Avibactam (AVI) intervention 2: Aztreonam (ATM) intervention 3: combination of Aztreonam - Avibactam (ATM-AVI) intervention 4: Placebo
Intervention descriptions: intervention 1: PART A: AVI IV infusion intervention 2: PART A: ATM IV infusion intervention 3: PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions. intervention 4: PART A, PART B, PART C: matching placebo IV infusions

Protocol document: