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KSP-1007 single ascending dose for Bacterial Infection

Phase 1
Waitlist Available
Research Sponsored by Sumitovant Biopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after start of dosing
Awards & highlights

Study 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)

Eligible Conditions
  • Bacterial Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after start of dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after start of dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events assessed by subject .
Secondary outcome measures
Cumulative amount of KSP-1007 excreted in urine over time
Cumulative amount of meropenem excreted in urine over time
Electrocardiogram
+6 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: KSP-1007 single ascending doseExperimental Treatment1 Intervention
Single, ascending intravenous dose of KSP-1007
Group II: KSP-1007 multiple ascending dose + Meropenem multiple doseExperimental Treatment2 Interventions
Multiple, ascending intravenous doses of KSP-1007 and multiple doses of meropenem (fixed dose)
Group III: KSP-1007 multiple ascending doseExperimental Treatment1 Intervention
Multiple, ascending, intravenous doses of KSP-1007
Group IV: Placebo single dosePlacebo Group1 Intervention
Single dose of placebo (0.9% normal saline)
Group V: Placebo multiple dosePlacebo Group1 Intervention
Multiple doses of placebo (0.9% saline)
Group VI: Placebo + Meropenem multiple dosePlacebo Group2 Interventions
Multiple doses of placebo (0.9% normal saline) plus multiple doses of meropenem (fixed dose)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KSP-1007
2022
Completed Phase 1
~130
Meropenem
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sumitovant Biopharma, Inc.Lead Sponsor
Hayes Dansky, M.D.Study DirectorSumitovant Biopharma, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
2022. "Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226923.
~38 spots leftby Apr 2025
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