A Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overall good health, on the basis of full physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- •Body weight 50 - 100 kilogram (kg), body mass index (BMI) 18 - 30 kilogram per meter square (kg/m^2), inclusive at screening
- •Platelet count within range: 145 to 350*10^9/liter (L), inclusive at screening
- •Hematologic values, coagulation profile, renal and liver function within normal range at screening or if out of range and considered not clinically significant by the investigator
- •Non-smoker for at least the previous 3 months prior to screening and negative urine cotinine test at screening and admission
排除标准
- •History of any clinically significant medical illness or disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- •Has a disease or disease treatment history associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease
- •Has a personal history of genetic or congenital prothrombotic condition or new conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction, cerebral vascular accident/stroke, deep vein thrombosis, pulmonary embolism, hemophilia, or menometrorrhagia
- •Participants who had received hematopoietic growth factors within 3 months prior to study drug administration
- •Donation of blood or blood components within 90 days prior to drug administration
研究组 & 干预措施
Cohort1: JNJ-2636682/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
干预措施: JNJ-26366821 (Drug)
Cohort1: JNJ-2636682/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 2: JNJ-26366821/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
干预措施: JNJ-26366821 (Drug)
Cohort 2: JNJ-26366821/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 3: JNJ-26366821/Placebo
Participants will receive single dose of JNJ-26366821 or placebo. The dose of JNJ-26366821 will be selected based on the safety, pharmacodynamics, and pharmacokinetics data from the previous Cohorts 1 and 2.
干预措施: JNJ-26366821 (Drug)
Cohort 3: JNJ-26366821/Placebo
Participants will receive single dose of JNJ-26366821 or placebo. The dose of JNJ-26366821 will be selected based on the safety, pharmacodynamics, and pharmacokinetics data from the previous Cohorts 1 and 2.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
时间窗: Up to Day 30
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
次要结局
- Apparent Elimination Half-Life (t1/2) of JNJ-26366821(Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30)
- Area Under the Plasma Concentration Versus Time Curve from Time 0 to Time of the Last Measurable Concentration AUC0-Last of JNJ-26366821(Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30)
- Change in Platelet Count from Baseline at Each Dose and Time(Baseline up to Day 30)
- Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821(Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30)
- Area Under the JNJ-26366821 Concentration Versus Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-26366821(Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30)
- Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-26366821(Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30)