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

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
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing a new drug called KSP-1007, both by itself and with an antibiotic named meropenem. Meropenem is an antibiotic used to treat serious infections. The study involves healthy Japanese individuals to check if the drug is safe and well-tolerated. KSP-1007 aims to help antibiotics work better against tough bacteria that are hard to treat.

Eligible Conditions
  • Moist Dressings Over Meshed Autografts
  • 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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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.
~31 spots leftby Dec 2025
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