drugset / Trial / NCT04482569

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin

NCT04482569

Phase 1 Completed 88 enrolled Evopoint Biosciences Inc.
RandomizedSequentialDouble-blindBasic science

Summary

This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.

Timeline

Start
2020-07-10
Primary completion
2021-02-28
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject XNW4107 Unknown 500 mg Intravenous