NCT03993639已完成2 期
A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
研究概览
简要总结
Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
详细描述
KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese subjects aged 20 to 55 years or younger at the submission of the written informed consent form
- •Women weighing 40 kg or more and 80 kg or less and men weighing 45 kg or more and 80 kg or less at the time of the preliminary examination
排除标准
- •Subjects with a current medical history or who have been judged to be inappropriate for the study (e.g., significant neurological, hepatic, renal, endocrine, cardiovascular, blood, gastrointestinal, respiratory, and metabolic diseases, malignancies, myeloproliferative disorder, or psychiatric disorders)
- •Individuals with alcohol or drug dependence, or individuals who have not tested negative for all drugs of abuse in the preliminary test
- •Subjects with a history or current history of drug allergy or symptomatic allergy
- •.Active infection or history of recurrent infection- However, only patients who are HBsantibody-positive by hepatitis B vaccination and whose HBV-DNA is less than the lower limit of quantitation will be allowed to participate in this study.
- •Subjects who used drugs within 2 weeks before administration of the investigational drug.
- •Subjects who have had at least 200 mL of blood drawn within 3 months before administration of the investigational drug.
- •Pregnant or lactating
研究组 & 干预措施
KRN125
Experimental
Single SC administration
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
时间窗: Baseline to Day 7
次要结局
- • Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL(Baseline to Day 15 or through study completion, an average of 1 year)
- • Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7(Baseline to Day 7)
- • Peripheral blood CD34 positive cell count(Baseline to Day 15 or through study completion, an average of 1 year)
- • Peripheral blood white blood cell count(Baseline to Day 15 or through study completion, an average of 1 year)
- • Time from baseline to peak peripheral blood CD34 positive cells(Baseline to Day 15 or through study completion, an average of 1 year)
- • Peripheral blood neutrophil count(Baseline to Day 15 or through study completion, an average of 1 year)
研究者
研究点 (1)
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