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

Overseen By Sam Azoulay, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sumitovant Biopharma, Inc.

Must not be taking: β-lactams, β-lactamase inhibitors

Disqualifiers: Gilbert's Syndrome, Pregnant, Lactating, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 days

123 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy subjects and has specific exclusion criteria, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

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.

Research Team

Hayes Dansky, M.D.

Principal Investigator

Sumitovant Biopharma, Inc.

Eligibility Criteria

Inclusion Criteria

Females that engage in heterosexual activity must agree to use a highly selective birth control (BC) method (< 1% failure rate per year) throughout the study, or have a documented reproductive status of non-childbearing based on medical history, or is postmenopausal

Males that engage in heterosexual activity that has the risk of pregnancy must agree to use effective BC and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication

Body mass index (BMI) 2: 18 kg/m2 and :s 32 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and repeat escalating doses of KSP-1007, alone and coadministered with meropenem

Up to 5 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 days

Treatment Details

Interventions

• KSP-1007
• Meropenem
• Placebo:0.9% sodium chloride

Participant Groups

Group I: KSP-1007 single ascending dose Experimental Treatment 1 Intervention

Single, ascending intravenous dose of KSP-1007

Group II: KSP-1007 multiple ascending dose + Meropenem multiple dose Experimental Treatment 2 Interventions

Multiple, ascending intravenous doses of KSP-1007 and multiple doses of meropenem (fixed dose)

Group III: KSP-1007 multiple ascending dose Experimental Treatment 1 Intervention

Multiple, ascending, intravenous doses of KSP-1007

Group IV: Placebo single dose Placebo Group 1 Intervention

Single dose of placebo (0.9% normal saline)

Group V: Placebo multiple dose Placebo Group 1 Intervention

Multiple doses of placebo (0.9% saline)

Group VI: Placebo + Meropenem multiple dose Placebo Group 2 Interventions

Multiple doses of placebo (0.9% normal saline) plus multiple doses of meropenem (fixed dose)

Who Is Running the Clinical Trial?

Sumitovant Biopharma, Inc.

Lead Sponsor

Trials

1

Recruited

120+