Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects - Trial NCT05226923
Access comprehensive clinical trial information for NCT05226923 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sumitovant Biopharma, Inc. and is currently Completed. The study focuses on Bacterial Infections. Target enrollment is 123 participants.
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Study Focus
Sponsor & Location
Sumitovant Biopharma, Inc.
Timeline & Enrollment
Phase 1
Jan 12, 2022
Oct 01, 2022
Primary Outcome
Incidence of adverse events assessed by subject .
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)
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05226923
Non-Device Trial