jRCT2071240121招募中不适用
A Clinical Pharmacology Study to Investigate the Safety, Tolerability and Pharmacokinetics of KSP-1007-05 in Combination with Meropenem in Healthy Japanese and Chinese Adult Male Participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Participant must be 18 to 45 years of age (inclusive), at the time of signing the informed consent.
- •Part 1 and Part 2 Cohort 1: Japanese healthy male adults, Part 2 Cohort 2: Chinese healthy male adults
- •Body weight within the range 50-80 kg (inclusive) and Body mass index (BMI) within the range 18.5-28.0 kg/m2 (inclusive)
- •Males with a woman of childbearing potential partner(s) must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control from signing informed consent to at least 30 days after the last dose of study interventions.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Participant with an educational level that allows for appropriate communication with the Investigator and the staff of the study site, and who are able to report subjective symptoms and others.
排除标准
- •Participant has a history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric or neurological disorders (including Parkinsons disease, convulsive disorders such as epilepsy), or skin diseases and is considered ineligible for the study by the Investigator.
- •Participant has an abnormal 12-lead ECG that may jeopardize the participants safety to participate in the study.
- •Participant who has a history of drug allergy.
- •Participant has a disorder or history of a disorder that may interfere with the metabolism, or excretion of the study intervention (including a clinically significant abnormality of the hepatic or renal system)
- •Participant who has experienced significant blood loss or donated 400 mL or more of blood within 90 days before the administration of study interventions, who donated 200 mL or more of blood within 30 days before the administration of study interventions, who donated blood components within 14 days before the administration of study interventions, or who plans to donate blood components or whole blood within 30 days after the follow-up.
- •Participant who does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
- •Participant has a history of alcohol abuse or drug abuse
- •Participant who has a history of excessive alcohol consumption (approximately 1.3 L or more of beer or 360 mL or more of Japanese sake, or 150 mL or more of Baijiu on average per day) within 6 months prior to screening.
- •Participant who has consumed alcoholic beverages from the day before the screening tests until the screening tests.
- •Participant who took alcohol after Day -
- •Participant who are unable to abstain from alcohol and smoking during the hospitalization period.
- •Participant who has a history of tobacco dependence, or who smoke more than an average of 20 cigarettes per day.
- •Participant who drinks large quantities of caffeinated beverages (coffee, tea, green tea, cola, energy drink, etc.) on a daily basis (approximately 1.8 L and more on average per day).
- •Participant who has a history of hospitalization (except for hospitalization for medical check-up) within 45 days prior to screening.
- •Participant who has used prescription or over-the-counter (OTC) medications within 14 days prior to the administration of study interventions.
- •Participant who previously received KSP-1007, KSP-1007-05 or meropenem
- •Participant who has participated in another clinical study and used the investigational intervention within 90 days prior to the screening, or who is currently participating in another clinical study.
- •Participant who has any of the following findings on 12-lead ECG:
- •Heart rate > 100 bpm or < 50 bpm
- •QRS interval > 120 msec
- •QTcF > 450 msec
- •PR interval > 220 msec
- •Participant who is positive in the immunological tests at screening.
- •Participant who has a clinically significant abnormality in the hematological tests, blood biochemistry tests (serum), or urinalysis at the screening or on Day -
- •Participant whose serum creatinine level exceeds the upper limit of normal (ULN) at the screening or on Day -
- •Participant who is positive in the urine drug test at screening or on Day -
- •Participant who has clinical symptoms suspected of being infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -1 or is positive in SARS-CoV-2 test* on Day -
- •Samples may be collected and tested between Day -4 and Day -2 only if the test cannot be performed on the day of admission.
- •Participant who, based on the physical examination and test results for eligibility assessments, are considered by the Investigators to have a medical condition that makes them unsuitable for this study.
- •Participant who, for any other reason, are considered by the Investigators to be unsuitable for this study
结局指标
主要结局
-
Adverse events, clinical laboratory tests, vital signs, and 12-lead electrocardiogram
次要结局
未报告次要终点
研究者
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