NCT05226923

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

Name: Clinical Trial NCT05226923
Creator: Sumitovant Biopharma, Inc.
Keywords: Bacterial Infections, KSP-1007, Phase 1, drug, clinical trial, United States of America

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

Sumitovant Biopharma, Inc.·Phase 1·ClinicalTrials.gov·drugCompleted

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Study focus

Disease/Condition: Bacterial Infections
Drug/Device/Intervention: KSP-1007
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Sumitovant Biopharma, Inc.
Location: Lenexa, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Jan 12, 2022
End date: Oct 01, 2022
Enrollment: 123 participants

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

Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05226923
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.