A Randomized, Parallel-group, Placebo-controlled, Double-blind Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple- dose Intravenous Administration of PCN-101 in Healthy Adult Male Subjects (Phase 1)

Matsumaru Takehisa0 个研究点目标入组 42 人开始时间: 2022年3月26日最近更新: 2023年11月20日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 42

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Intravenous administration of a single dose of PCN-101 30-120 mg, and multiple doses of PCN-101 60 mg twice weekly for 2 weeks in healthy Japanese adult subjects was safe and well tolerated. - Cmax and AUC of PCN-101 were dose proportional within the dose range of 30 to 120 mg after a single-dose intravenous administration. - It was demonstrated that there was no accumulation of PCN-101 following multipledose intravenous administration from the results of the mean R(Cmax) and R(AUC72h) on Day 12.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 < 40age old（—）
性别: Male

入选标准

•1) Healthy Japanese male subjects aged 20 years or older and younger than 40 years
•at the time of informed consent
•2) Subjects with a body mass index (BMI = body weight [kg] / height [m]2) of
•18.5 kg/m2 or higher and lower than 25.0 kg/m2 at screening
•3) Subjects with the ability to provide written informed consent prior to initiation of
•any trial-related procedures, and the ability, in the opinion of the principal
•investigator or subinvestigator, to comply with all the requirements of the trial

排除标准

•1) Subjects with clinically significant abnormalities (eg, significant deviation from the normal range) of screening examinations, admission examinations, or in the medical history that could potentially pose a risk to the subject or affect such endpoints as absorption, distribution, metabolism, or excretion of the drug as judged by the principal investigator, subinvestigator, or sponsor. These include, but are not limited to, a history or current symptoms of cardiac, hepatic, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
•2) Subjects with a systolic blood pressure of more than 140 mmHg or less than 100 mmHg or a diastolic blood pressure of more than 90 mmHg or less than 50 mmHg in a supine, sitting, or standing position while at rest for 3 minutes or longer (at screening or admission), or with a decrease in blood pressure due to standing (difference betweensupine systolic blood pressureand standing systolic blood pressure) of more than 20 mmHg (at screening). However, if the principal investigator or subinvestigator determines that there are no clinical problems, even if the parameter is outside the range, judgement on exclusion should be made after remeasurement.
•3) Subjects with a pulse rate outside the range of 50 to 90 bpm in a supine, sitting, or standing position while at rest for 3 minutes or longer (at screening or admission) However, if the principal investigator or subinvestigator determines that there are no clinical problems, even if the parameter is outside the range, judgement on exclusion should be made after remeasurement.
•4) Subjects with clinically significant ECG findings on 12-lead ECG; eg, atrioventricular block, QRS interval of at least 120 msec, QTcF interval of at least 450 msec, etc. (at screening or admission)
•5) Subjects who fall under the following criteria for hepatitis
•-Subjects with a history or current symptoms of hepatitis B, or current symptoms of hepatitis C. Subjects who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody at screening
•-Subjects with a history or current symptoms of alcoholic hepatitis or nonalcoholic steatohepatitis
•6) Subjects who have acquired immunodeficiency syndrome (AIDS) or a history of human immunodeficiency virus (HIV) infection. Subjects who test positive for HIV or syphilis (at screening). Subjects with a positive polymerase chain reaction (PCR) test for SARS coronavirus 2 (SARS-CoV-2) (at admission)
•7) Subjects with mental disorders or a history of the following mental disorders based on the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
•-Schizophrenia spectrum disorders and other psychotic disorders, bipolar and related disorders, depressive disorders, substance-related disorders and addictive disorders, and personality disorders

研究者

发起方

Matsumaru Takehisa

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