drugset
drugset / Trial / NCT03685084

Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers

NCT03685084 ↗

Phase 1 Completed 56 enrolled Allecra
RandomizedSequentialQuadruple-blindOther

Summary

* To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 (SAD \& MAD) in healthy male subjects. * To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in healthy male subjects

Timeline

Start
2013-10-10
Primary completion
2014-01-13
Completion
2014-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefepime Small molecule 1 g Intravenous
Subject Piperacillin Small molecule 3 g Intravenous
Subject enmetazobactam Small molecule 600 mg Intravenous
Subject enmetazobactam Small molecule 1 g Intravenous
Subject enmetazobactam Small molecule 2 g Intravenous
Subject enmetazobactam Small molecule 4 g Intravenous

Indications

No indication recorded.