NCT03657238已完成1 期
A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single S.C. Doses of RD01 (Pegerythropoietin) in Healthy Chinese Subjects
Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2018年4月8日最近更新:
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
- 试验地点
- 1
- 主要终点
- incidence of Adverse Events
研究概览
简要总结
A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects
详细描述
A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation study to evaluate the Safety, Tolerability and Pharmacokinetics of single S.C. doses of RD01 (Pegerythropoietin) in Healthy Chinese Subjects. Doses were escalated from 0.2μg/kg up to 4.8μg/kg with 12 subjects (randomized to 5:1 for test or placebo) in every cohort.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18~60, both male and female
- •Healthy adults without obvious organic diseases and nervous/mental diseases
- •BMI 19~26 kg/m2, inclusive
- •Subject is willing and able to provide written informed consent, and would complete the whole study procedures
- •Serum ferritin level is within the reference range at screening within 4 weeks before enrollment
- •Should be fully recovered, when has received surgical treatment
排除标准
- •Has allergy history or past drug allergy history, or allergy history to polyethylene glycol
- •Has taken any drug within 5 half-time or 4 weeks before enrollment
- •Has taken any drug known to harm organ within 12 weeks before enrollment
- •Participated in other clinical trials within 12 weeks before enrollment
- •Donated blood or received blood transfusion, or received therapy of recombinant erythrocytogenetic stimulating protein or rHuEPO within 12 weeks before enrollment
- •Female subject receives therapy of hormone after menopause
- •Subject with clinically significant abnormal of lab tests determined by the investigator (subjects with Hb or Rtc level outrange the up-limit of reference were suggested to be excluded)
- •Subject with HBsAg, HBeAg, HCV-Ab, HIV-Ab or Treponema pallidum antibody positive
- •Clinically diagnosed as vitamin B12 or folic acid deficiency
- •Previous history of coronary heart disease or congestive heart failure, or ECG shows clinical significance of abnormalities
- •With history of malignant tumors or suspicious
- •Subject with active infection
- •History of autoimmune disease, or being treated with immunosuppressive agents
- •With severe, progressive or uncontrolled diseases of liver, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerves or brain
- •Pregnant or lactating women, or subject planning to has descendants during trial or within 12 weeks after dosing
- •Drug abusers, drug addicts, or smokers (5 or more cigarettes per day), alcoholics (14 or more units per week, 1 unit = 360 mL of beer or 150 mL of wine or 45 mL of alcohol 40% or more)
- •Other factors that might influence the attendance determined by investigators, including poor compliance (long-term travel, planned relocation, mental illness, lack of motivation, etc.)
研究组 & 干预措施
Experimental
Experimental
Doses were escalated from 0.2μg/kg up to 4.8μg/kg
干预措施: RD01 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of Adverse Events
时间窗: up to 35 days
incidence of adverse events using the NCI Common Terminology Criteria for Adverse Events version 4.0.
次要结局
- terminal elimination half life（t½）(for 35days)
- time to reach Cmax （Tmax）(for 35days)
- maximum concentration （Cmax）(for 35days)
- the changes of hemoglobin (g/L) after treatment(for 35days)
- the changes of reticulocyte (10^9/L) after treatment(for 35days)
- the changes ofHematocrit（%） after treatment(for 35days)
- the changes of erythrocyte（10^12/L） after treatment(for 35days)
研究者
研究点 (1)
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