NCT01093729已完成1 期
A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 41 人开始时间: 2010年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Safety
研究概览
简要总结
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.
详细描述
Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age range 20 to 45 years
- •Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
- •Exclusion Criteria
- •Acute disease within 1 month prior to start of study drug administration
- •Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
- •History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
- •Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)
- •Laboratory test results
- •AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit
- •Total bilirubin > 1.5Xupper normal limit
- •Absolute Neutrophil Count < 1500 mm2
- •History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)
- •Prior exposure to products related to Exenatide
- •Use of any prescription medication within 14 days prior to Day 1
- •Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)
- •Subject who can't eat standard meal received by Korea University Anam Hospital
- •Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month
- •Participation in another clinical study within 60 days prior to start of study drug administration
- •Taking Caffein(> 5cups/ day) or alcohol abuse (> 30g/ day) or excessive smoker(> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
排除标准
- 未提供
研究组 & 干预措施
Cohort1
Experimental
HM11260C 0.5mcg/kg or Placebo
干预措施: HM11260C (Drug)
Cohort2
Experimental
HM11260C 2mcg/kg or Placebo
干预措施: HM11260C (Drug)
Cohort3
Experimental
HM11260C 4mcg/kg or Placebo
干预措施: HM11260C (Drug)
Cohort4
Experimental
HM11260C 8mcg/kg or Placebo
干预措施: HM11260C (Drug)
Cohort5
Experimental
HM11260C 14mcg/kg or Placebo
干预措施: HM11260C (Drug)
结局指标
主要结局
Safety
时间窗: 1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day
Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
次要结局
未报告次要终点
研究者
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