A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
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Study Design
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Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
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Four ascending dose cohorts.
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In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
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Objectives
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The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.
详细描述
The secondary objectives of the study are as follows:
- To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.
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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
- •Body mass index of ≥19 and ≤26 Subject
- •Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
- •Able to participate in all procedure
- •SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
- •AST, ALT <1.5 X UNL, CPK < 2 X UNL
- •Able to abstain from alcohol and smoke during study period
- •Consented to contraception until 2 month after end of the study
排除标准
- •Acute infection history within 14 days
- •Prior exposure or hypersensitivity to recombinant human growth hormone
- •Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
- •History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
- •psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
- •Caffeine, alcohol and smoke abuse
- •History of hemophilia or anticoagulant treatment
- •Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration
- •History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines
- •Blood donation or significant blood loss within 60 days prior to Day
- •Plasma donation or transfusion within 30 days prior to Day
- •Receipt of another investigational medication within 60 days prior to Day 1
- •Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day
- •Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions
研究组 & 干预措施
cohort 1
HM10560A 0.089 mg/kg or Placebo
干预措施: HM10560A (Drug)
cohort 1
HM10560A 0.089 mg/kg or Placebo
干预措施: Placebo (Drug)
cohort 2
HM10560A 0.179 mg/kg or Placebo
干预措施: HM10560A (Drug)
cohort 3
HM10560A 0.357 mg/kg or Placebo
干预措施: Placebo (Drug)
cohort 2
HM10560A 0.179 mg/kg or Placebo
干预措施: Placebo (Drug)
cohort 3
HM10560A 0.357 mg/kg or Placebo
干预措施: HM10560A (Drug)
cohort 4
HM10560A 0.714 mg/kg or Placebo
干预措施: HM10560A (Drug)
cohort 4
HM10560A 0.714 mg/kg or Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety
时间窗: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration
Investigate Safety of HM10560A: * Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability
次要结局
未报告次要终点