A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
- •Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
- •Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
- •Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- •Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
- •Clinically significant abnormal physical exam at Screening or Day -1
- •Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
- •Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
研究组 & 干预措施
Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: JNJ-64179375 0.3 mg/kg (Drug)
Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: Placebo (Other)
Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: JNJ-64179375 1.0 mg/kg (Drug)
Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: Placebo (Other)
Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: JNJ-64179375 2.5 mg/kg (Drug)
Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
干预措施: Placebo (Other)
Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
干预措施: Placebo (Other)
Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
干预措施: JNJ-64179375 (Dose to be Determined) (Drug)
Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
干预措施: Placebo (Other)
Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
干预措施: JNJ-64179375 (Dose to be Determined) (Drug)
Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1.
干预措施: JNJ-64179375 1.0 mg/kg (Drug)
Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1.
干预措施: Placebo (Other)
结局指标
主要结局
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function(Predose, Days 1 and 14 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)(Predose, Day 1 and 14 post-dose)
- Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)(Predose, Day 1, 2, 4, and 14 post-dose)
- Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1 and 2: Immunogenicity of JNJ-64179375(Predose, Day 7, 14, 29, 57, 85 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)(Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)(Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose)
- Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375(Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose)
- Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1: Total Systemic Clearance (CL) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose(Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)(Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer(Predose, Day 1 and 14 post-dose)
- Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)(Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose)