NCT05226923

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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Sumitovant Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Detailed description

Carbapenem-resistant Gram-negative bacteria are responsible for serious, life-threatening infections and are regarded as an urgent threat by the Centers for Disease Control and Prevention and the World Health Organizations. One principal mechanism of carbapenem resistance is bacterial production of carbapenemases, which reduce the effectiveness of meropenem and other carbapenem class antibiotics. Sumitovant Biopharma is developing a fixed combination of meropenem and KSP-1007 for the treatment of serious bacterial infections.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	KSP-1007	Single and multiple doses, intravenous administration
OTHER	Placebo:0.9% sodium chloride	Single and multiple doses, intravenous administration
DRUG	Meropenem	Multiple doses, intravenous administration

Timeline

• Start date: 2022-01-12
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-02-07
• Last updated: 2022-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study