NCT01013064已完成1 期
A Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Korean Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年11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
- 48
- 试验地点
- 1
- 主要终点
- Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
研究概览
简要总结
Study design:
- Randomized, double-blind, placebo-controlled, sequential dose escalation
- Six ascending dose cohorts are planned
Primary Objective:
- To evaluate the safety profile of single escalating intravenous dose levels of HM10760A
详细描述
Secondary objectives:
- To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
- To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
- To determine the pharmacologically active dose(PAD) of HM10760A
- To assess the immunogenicity of a single IV dose of HM10760A
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 20 to 55 years
- •Able and willing to provided written informed consent
- •Hemoglobin < 16 g/dL
排除标准
- •Prior exposure to EPO, darbepoetin, other EPO support proteins
- •hypersensitivity to EPO, darbepoetin, E.coli derived proteins
- •Hemoglobinopathy
- •SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
- •Chronic, uncontrolled, or symptomatic inflammatory disease
- •Malignancy(except non-melanoma skin cancer)
研究组 & 干预措施
Cohort5
Experimental
干预措施: HM10760A or Placebo (Drug)
Cohort1
Experimental
干预措施: HM10760A or Placebo (Drug)
Cohort2
Experimental
干预措施: HM10760A or Placebo (Drug)
Cohort3
Experimental
干预措施: HM10760A or Placebo (Drug)
Cohort4
Experimental
干预措施: HM10760A or Placebo (Drug)
Cohort6
Experimental
干预措施: HM10760A or Placebo (Drug)
结局指标
主要结局
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
时间窗: 84 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy VolunteersEpilepsyNCT01879332Bial - Portela C S.A.16
已完成
1 期
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian SubjectsHealthyNCT01037543Hanmi Pharmaceutical Company Limited84
已完成
1 期
A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy SubjectsMigraineNCT06158737Shanghai Junshi Bioscience Co., Ltd.48
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee PainOsteoarthritisNCT02318407Amgen24
已完成
1 期
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in ChinaParkinson DiseaseNCT04162275Yiling Pharmaceutical Inc.34