NCT01742221已完成1 期
A Phase 1b, Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of HemaMax in healthy subjects.
研究概览
简要总结
This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.
详细描述
A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and Female subjects, who have signed the informed consent form must meet all of the following criteria
- •18 to 45 years of age
- •Body mass index (BMI) > 19 and < 0 kg/m2
- •Normal ECG, vital signs and laboratory test results
- •Use of effective birth control method and abstinence from sex
- •Negative pregnancy test and drug screen
排除标准
- •Subjects with any of the following characteristics will be considered ineligible:
- •History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
- •Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
- •Current drug or alcohol addiction
- •History of clinically significant allergy of any kind
- •Prior use of IL-12 or HemaMax
- •Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months
研究组 & 干预措施
HemaMax
Experimental
Single subcutaneous 12 microgram dose of HemaMax
干预措施: HemaMax (Biological)
Placebo
Placebo Comparator
Single subcutaneous dose
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the safety and tolerability of HemaMax in healthy subjects.
时间窗: 3 months
Number of subjects with adverse events as a measure of safety and tolerability
次要结局
- To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects(3 months)
研究者
研究点 (1)
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