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

NCT ID: NCT05226923

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2022-10-01

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.

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

KSP-1007 single ascending dose

Single, ascending intravenous dose of KSP-1007

Group Type: EXPERIMENTAL

KSP-1007

Intervention Type: DRUG

Single and multiple doses, intravenous administration

Placebo single dose

Single dose of placebo (0.9% normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo:0.9% sodium chloride

Intervention Type: OTHER

Single and multiple doses, intravenous administration

KSP-1007 multiple ascending dose

Multiple, ascending, intravenous doses of KSP-1007

Group Type: EXPERIMENTAL

KSP-1007

Intervention Type: DRUG

Single and multiple doses, intravenous administration

Placebo multiple dose

Multiple doses of placebo (0.9% saline)

Group Type: PLACEBO_COMPARATOR

Placebo:0.9% sodium chloride

Intervention Type: OTHER

Single and multiple doses, intravenous administration

KSP-1007 multiple ascending dose + Meropenem multiple dose

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

Group Type: EXPERIMENTAL

KSP-1007

Intervention Type: DRUG

Single and multiple doses, intravenous administration

Meropenem

Intervention Type: DRUG

Multiple doses, intravenous administration

Placebo + Meropenem multiple dose

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

Group Type: PLACEBO_COMPARATOR

Placebo:0.9% sodium chloride

Intervention Type: OTHER

Single and multiple doses, intravenous administration

Meropenem

Intervention Type: DRUG

Multiple doses, intravenous administration

Interventions

KSP-1007

Single and multiple doses, intravenous administration

Intervention Type: DRUG

Placebo:0.9% sodium chloride

Single and multiple doses, intravenous administration

Intervention Type: OTHER

Meropenem

Multiple doses, intravenous administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sumitovant Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayes Dansky, M.D.

Role: STUDY_DIRECTOR

Sumitovant Biopharma, Inc.

Locations

PRA Health Sciences

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

KSP-1007-101

Identifier Type: -

Identifier Source: org_study_id