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

Primary Purpose

Bacterial Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

KSP-1007

Placebo:0.9% sodium chloride

Meropenem

About this trial

This is an interventional other trial for Bacterial Infections focused on measuring Bacterial Disease, Bacterial Infection, Bacterial Infections, Bacterial, Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male or female subjects 18 to 55 years of age, inclusive
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

Exclusion Criteria:

History of Gilbert's Syndrome
History of severe allergic reactions to β-lactams or β-lactamase inhibitors or a history allergic reactions to multiple medications.
Pregnant female, determined by positive serum or urine human chorionic gonadotropin pregnancy test at Screening, or prior to dosing
Lactating female
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of > 499 mL within 56 days prior to Day 1
Participation in a study with an investigational drug or device study with last dose of investigational drug within 30 days (90 days if the study involved a biologic, cellular, or vaccine product) or 5 half-lives, whichever is longer, before study treatment administration
Subjects with abnormal hepatic and/or renal function, that could interfere with the metabolism, and/or excretion of the study treatments
Abnormal blood pressure, either low (defined as < 90 mmHg systolic and/ or < 45 mmHg diastolic) or high (defined as > 140 mmHg systolic and/ or > 90 mmHg diastolic) at Screening
Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV at Screening. Subjects who test positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) also will be ineligible. Evidence of prior HBV vaccination (positive hepatitis B surface antibody [HBsAb)) is not exclusionary.
Subjects unable to abstain from alcohol for 48 hours prior to admission through to completion of the Follow-up visit

Sites / Locations

PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

KSP-1007 single ascending dose

Placebo single dose

KSP-1007 multiple ascending dose

Placebo multiple dose

KSP-1007 multiple ascending dose + Meropenem multiple dose

Placebo + Meropenem multiple dose

Arm Description

Single, ascending intravenous dose of KSP-1007

Single dose of placebo (0.9% normal saline)

Multiple, ascending, intravenous doses of KSP-1007

Multiple doses of placebo (0.9% saline)

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

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

Outcomes

Primary Outcome Measures

Incidence of adverse events assessed by subject .

Incidence of adverse events

Secondary Outcome Measures

Peak plasma concentration of KSP-1007

The plasma concentration of KSP-1007 will be measured over time, and the peak plasma concentration, or Cmax, of KSP-1007 will be determined

Plasma concentration of KSP-1007 versus time curve

The plasma concentration of KSP-1007 will be measured over time and the area under the curve, or AUC, of KSP-1007 will be determined

Cumulative amount of KSP-1007 excreted in urine over time

Total amount of unchanged drug excreted in urine over a dosing interval

Renal clearance of KSP-1007 in urine over time

Renal clearance in urine. Urine was collected up to 5 days after dosing.

Peak plasma concentration of meropenem

The plasma concentration of meropenem will be measured over time, and the peak plasma concentration, or Cmax, of meropenem will be determined

Plasma concentration versus time curve of meropenem

The plasma concentration of meropenem will be measured over time and the area under the curve, or AUC, of meropenem will be determined

Cumulative amount of meropenem excreted in urine over time

Total amount of unchanged drug excreted in urine over a dosing interval.

Renal clearance of meropenem in urine over time

Renal clearance in urine. Urine was collected up to 5 days after dosing.

ECG QTcF interval

Change from baseline QTcF interval

Full Information

NCT ID

NCT05226923

First Posted

January 7, 2022

Last Updated

October 26, 2022

Sponsor

Sumitovant Biopharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05226923

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 12, 2022 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sumitovant Biopharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections

Keywords

Bacterial Disease, Bacterial Infection, Bacterial Infections, Bacterial, Healthy Volunteers

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KSP-1007 single ascending dose

Arm Type

Experimental

Arm Description

Single, ascending intravenous dose of KSP-1007

Arm Title

Placebo single dose

Arm Type

Placebo Comparator

Arm Description

Single dose of placebo (0.9% normal saline)

Arm Title

KSP-1007 multiple ascending dose

Arm Type

Experimental

Arm Description

Multiple, ascending, intravenous doses of KSP-1007

Arm Title

Placebo multiple dose

Arm Type

Placebo Comparator

Arm Description

Multiple doses of placebo (0.9% saline)

Arm Title

KSP-1007 multiple ascending dose + Meropenem multiple dose

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo + Meropenem multiple dose

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

KSP-1007

Intervention Description

Single and multiple doses, intravenous administration

Intervention Type

Other

Intervention Name(s)

Placebo:0.9% sodium chloride

Intervention Description

Single and multiple doses, intravenous administration

Intervention Type

Drug

Intervention Name(s)

Meropenem

Intervention Description

Multiple doses, intravenous administration

Primary Outcome Measure Information:

Title

Incidence of adverse events assessed by subject .

Description

Incidence of adverse events

Time Frame

up to Day 14

Secondary Outcome Measure Information:

Title

Peak plasma concentration of KSP-1007

Description

The plasma concentration of KSP-1007 will be measured over time, and the peak plasma concentration, or Cmax, of KSP-1007 will be determined

Time Frame

Up to 5 days after dosing

Title

Plasma concentration of KSP-1007 versus time curve

Description

The plasma concentration of KSP-1007 will be measured over time and the area under the curve, or AUC, of KSP-1007 will be determined

Time Frame

Up to 5 days after dosing

Title

Cumulative amount of KSP-1007 excreted in urine over time

Description

Total amount of unchanged drug excreted in urine over a dosing interval

Time Frame