A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Interventional Study of JNJ-61178104 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants.
详细描述
This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participant currently has or has a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, cardiac, vascular, metabolic, endocrine, rheumatologic, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- •Participant has a QT corrected according to Fridericia's formula (QTcF) interval >450 msec, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome) at Screening and at Day -1
- •Participant has had major surgery, (example, requiring general anesthesia) within 4 months before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 17 weeks after the last dose of study drug administration
- •Participant plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through the end of the study
- •Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-61178104 and its excipients used in this study
研究组 & 干预措施
Dose 1: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
干预措施: JNJ-61178104 Intravenous (Drug)
Dose 1: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
干预措施: Placebo (Drug)
Dose 2: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
干预措施: JNJ-61178104 Intravenous (Drug)
Dose 2: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
干预措施: Placebo (Drug)
Dose 3: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
干预措施: JNJ-61178104 Intravenous (Drug)
Dose 3: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
干预措施: Placebo (Drug)
Dose 4: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
干预措施: JNJ-61178104 Intravenous (Drug)
Dose 4: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
干预措施: Placebo (Drug)
Dose 5: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
干预措施: JNJ-61178104 Intravenous (Drug)
Dose 5: JNJ-61178104 OR Placebo IV
Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
干预措施: Placebo (Drug)
Dose 6: JNJ-61178104 OR Placebo SC
Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.
干预措施: JNJ-61178104 Subcutaneous (Drug)
Dose 6: JNJ-61178104 OR Placebo SC
Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
时间窗: Day 113
次要结局
- Serum Concentration of JNJ-61178104(Up to Day 113)
- Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- JNJ-61178104 Antibodies Concentration(Up to Day 113)
- Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration(Up to Day 113)
- Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Cytokine Concentrations(Predose, Up to Day 113)
- Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration(Up to Day 113)
- Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration(Up to Day 113)