Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Avibactam · 1 trial · 2 indications
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...
Avibactam is an investigational small molecule being developed for complicated infections and bacterial infections. It is a beta-lactamase inhibitor studied in combination with aztreonam to treat serious bacterial infections. The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.
Avibactam is a beta-lactamase inhibitor that works by blocking bacterial enzymes that inactivate beta-lactam antibiotics. By inhibiting these enzymes, it helps restore the activity of antibiotics like aztreonam against resistant bacteria. This mechanism is being studied for treating complicated infections caused by drug-resistant pathogens.
Avibactam is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on the drug for infectious disease indications, specifically complicated infections and bacterial infections.
Avibactam is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in early-stage trials to evaluate its safety and tolerability, and it remains in active clinical investigation.
Avibactam has one completed Phase 1 clinical trial registered as NCT01689207, titled "To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)." This randomized, double-blind, placebo-controlled study enrolled 222 participants in the United Kingdom to evaluate the drug's safety and tolerability.