drugset
drugset / Trial / NCT04787562

Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function

NCT04787562 ↗

Phase 1 Completed 39 enrolled Evopoint Biosciences Inc.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function.

Timeline

Start
2021-02-25
Primary completion
2021-10-30
Completion
2022-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cilastatin Small molecule 200 mg Intravenous
Subject Cilastatin Small molecule 500 mg Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 200 mg Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 500 mg Intravenous
Subject XNW4107 Unknown 100 mg Intravenous
Subject XNW4107 Unknown 250 mg Intravenous

Indications

bacterial infectious disease