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

NCT05226923 | Completed Phase 1 FDA Drug

• 1 other identifier: KSP-1007-101
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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)

Conditions

Bacterial Infections

Keywords

Bacterial Disease; Bacterial Infection; Bacterial Infections; Bacterial; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events assessed by subject .

  Incidence of adverse events

  up to Day 14

Secondary Outcomes (9)

• Peak plasma concentration of KSP-1007

  Up to 5 days after dosing

• Plasma concentration of KSP-1007 versus time curve

  Up to 5 days after dosing

• Cumulative amount of KSP-1007 excreted in urine over time

  Up to 5 days after start of dosing

• Renal clearance of KSP-1007 in urine over time

  Up to 5 days after start of dosing

• Peak plasma concentration of meropenem

  Up to 5 days after start of dosing

Study Arms (6)

KSP-1007 single ascending dose

EXPERIMENTAL

Single, ascending intravenous dose of KSP-1007

Drug: KSP-1007

Placebo single dose

PLACEBO COMPARATOR

Single dose of placebo (0.9% normal saline)

Other: Placebo:0.9% sodium chloride

KSP-1007 multiple ascending dose

EXPERIMENTAL

Multiple, ascending, intravenous doses of KSP-1007

Drug: KSP-1007

Placebo multiple dose

PLACEBO COMPARATOR

Multiple doses of placebo (0.9% saline)

Other: Placebo:0.9% sodium chloride

KSP-1007 multiple ascending dose + Meropenem multiple dose

EXPERIMENTAL

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

Drug: KSP-1007; Drug: Meropenem

Placebo + Meropenem multiple dose

PLACEBO COMPARATOR

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

Other: Placebo:0.9% sodium chloride; Drug: Meropenem

Interventions

KSP-1007 DRUG

Single and multiple doses, intravenous administration

KSP-1007 multiple ascending dose; KSP-1007 multiple ascending dose + Meropenem multiple dose; KSP-1007 single ascending dose

Placebo:0.9% sodium chloride OTHER

Single and multiple doses, intravenous administration

Placebo + Meropenem multiple dose; Placebo multiple dose; Placebo single dose

Meropenem DRUG

Multiple doses, intravenous administration

KSP-1007 multiple ascending dose + Meropenem multiple dose; Placebo + Meropenem multiple dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subjects unable to abstain from alcohol for 48 hours prior to admission through to completion of the Follow-up visit

Sponsors & Collaborators

• Sumitovant Biopharma, Inc.: lead

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hayes Dansky, M.D.

  Sumitovant Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 7, 2022
• Study Start: January 12, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)