drugset / Trial / NCT05226923
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
RandomizedParallel-groupDouble-blindOther
Summary
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
Timeline
- Start
- 2022-01-12
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KSP-1007 | Unknown | — | Intravenous |
| Subject | Meropenem | Small molecule | — | Intravenous |