Status:
COMPLETED
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
Lead Sponsor:
Sumitovant Biopharma, Inc.
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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) esc...
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 Worl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05226923
Start Date
January 12 2022
End Date
October 1 2022
Last Update
October 27 2022
Active Locations (1)
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1
PRA Health Sciences
Lenexa, Kansas, United States, 66219