Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01689207 | To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) | PHASE1 | COMPLETED | 222 | — | — | Sep 1, 2012 | Dec 1, 2014 | Sep 6, 2017 | 1 | United Kingdom |
from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.
| Arm | Type | Description |
|---|---|---|
| Drug: A | EXPERIMENTAL | Avibactam (AVI) |
| Drug: B | EXPERIMENTAL | Aztreonam (ATM) |
| Drug: C | EXPERIMENTAL | combination of Aztreonam-Avibactam (ATM-AVI) |
| Drug: D | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| Avibactam (AVI) | DRUG | PART A: AVI IV infusion |
| Aztreonam (ATM) | DRUG | PART A: ATM IV infusion |
| combination of Aztreonam - Avibactam (ATM-AVI) | DRUG | PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions. |
| Placebo | DRUG | PART A, PART B, PART C: matching placebo IV infusions |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated ve...