Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
详细描述
This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.
Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.
The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.
Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed breast cancer，received chemotherapy.
- •ECOG performance status 0 or
- •ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
- •Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
- •No obvious abnormal ecg examination.
- •Cr，TBIL, AST, ALT≤1.5×ULN，no serious underlying disease.
- •Signed informed consent.
排除标准
- •Chemotherapy within past 4 weeks.
- •Uncontrolled inflammatory disease,axillary temperature≥38℃.
- •Merging other malignant tumor.
- •Pregnancy or nursing status.
- •Participation in another clinical trial with and investigational product within 3 months prior to study entry.
- •Severe diabetes mellitus, or poor blood sugar controller.
- •Allergic disease or allergic constitution. History of protein allergy.
- •History of drug addiction and alcoholism.
- •Hematopoietic stem cell transplantation or organ transplantation.
- •Received antibiotic treatment within 72 hours before chemotherapy.
- •Long-term use of hormones or immunosuppressive agents.
- •Severe mental or neurological disorders.
- •Chronic disease of severe cardiac, kidney and liver.
- •Other conditions that would be excluded from this study according to doctors'judgment.
研究组 & 干预措施
single injection-1.8mg
rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
干预措施: rHSA/GCSF (Drug)
single injection-2.1mg
rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
干预措施: rHSA/GCSF (Drug)
single injection-2.4mg
rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
干预措施: rHSA/GCSF (Drug)
multiple injection-1.8mg
rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
干预措施: rHSA/GCSF (Drug)
multiple injection-2.1mg
rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
干预措施: rHSA/GCSF (Drug)
multiple injection-2.4mg
rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
干预措施: rHSA/GCSF (Drug)
结局指标
主要结局
Number of adverse events
时间窗: 14 days
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
次要结局
- AUC(14 days)