A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
研究概览
简要总结
Study design:
This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.
详细描述
Primary objective:
to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a
Secondary objective:
to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 18 - 45 Years, Inclusive
- •BMI: 18.0 - 28.0 kg/m2
- •Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History
排除标准
- •Mental Handicap
- •Evidence of Clinically Relevant Pathology
- •History of Type 1 Diabetes or Thyroid Disease
结局指标
主要结局
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
时间窗: 43 days
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.
次要结局
未报告次要终点