drugset / Trial / NCT04482569
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XNW4107 | Unknown | 500 mg | Intravenous |