NCT01037543已完成1 期
A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 84 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Samples for immunogenicity
研究概览
简要总结
Study Design
- Randomized, double-blind, placebo-controlled, escalating single-dose design.
- Six ascending dose cohorts
- In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
- Primary Objective
- to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.
详细描述
Secondary objectives:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- to compare the PK of HM10460A in Japanese and Caucasian subjects.
- to assess the relationship between the serum concentration of HM10460A and absolute neutrophil count (ANC).
- to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood.
- To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.
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
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 18 - 29.9 kg/m2
- •have not used tobacco or nicotine containing products for at least 3 months prior to dosing
- •be able to remain abstinent throughout the study.
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •positive urine drug/alcohol testing
- •Positive for HIV, HBsAg, HCV ab
- •History of anaphylactic reaction to medicine or environmental exposure
研究组 & 干预措施
Cohort 1
Experimental
1.1 mcg/kg of HM10460A, placebo, or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
Cohort 2
Experimental
3.3 mcg/kg HM10460A, placebo or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
Cohort 3
Experimental
10 mcg/kg of HM10460A, placebo, or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
Cohort 4
Experimental
30 mcg/kg of HM10460A, placebo, or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
Cohort 5
Experimental
90 mcg/kg or HM10460A, placebo, or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
Cohort 6
Experimental
270 mcg/kg of HM10460A, placebo, or Neulasta
干预措施: HM10460A or placebo or Neulasta (Drug)
结局指标
主要结局
Samples for immunogenicity
时间窗: Days -1, 15, 22, and 42.
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).
时间窗: Time points where appropriate.
次要结局
- PK parameters measured from Serum and Urine samples.(Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose.)
- Calculation of ANC and CD34+ cell counts.(pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.)
研究者
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