drugset / Trial / NCT05226923

Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects

NCT05226923

Phase 1 Completed 123 enrolled Sumitovant Biopharma, Inc.
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

EvaluationDrugModalityDoseRoute
Subject KSP-1007 Unknown Intravenous
Subject Meropenem Small molecule Intravenous