A Phase 2 Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)
研究概览
简要总结
The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.
详细描述
This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria
- •≥18 to ≤75 years of age
- •Body mass index (BMI) ≥ 18 and ≤ 35 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)
- •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
Single subcutaneous 12 microgram dose of HemaMax
干预措施: HemaMax (Biological)
Placebo
Single subcutaneous dose
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)
时间窗: 3 months
Number of subjects with adverse events as a measure of safety and tolerability
次要结局
- Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)(3 months)
- Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)(3 months)
- Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)(3 months)