A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.
详细描述
Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.
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
- Double (Participant, Investigator)
盲法说明
double blind (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form;
- •Healthy adult volunteers aged between 18 and 45, male or female;
- •Medical examination as required within 28 days, body mass index (BMI) 19.0 ~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both;
- •Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
- •5.Subject can communicate well with the investigators and complete the study according to the study regulations.
排除标准
- •Pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age;
- •Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
- •History of drug abuse, or positive urine test for drug;
- •History of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. History of high blood pressure, or clinically significant systolic blood pressure≥140 mmHg/diastolic blood pressure≥90 mmHg;
- •Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
- •Participated in other clinical trials of drug or used drugs harmful to major organs within 3 months;
- •Blood donation within 3 months;
- •Used prescription or OTC drugs within 14 days;
- •Left ventricular ejection fraction (LVEF) < 60%;
- •ALT or AST > 1.5 ULN, Cr > ULN;
- •WBC < 0.8 LLN or > 1.2 ULN; ANC < 0.8 LLN; PLT < 0.8 LLN; HGB < 0.9LLN.
- •HBs-Ag, HCV-Ab, anti-HIV or TP-Ab positive;
- •Anti-drug antibody (ADA) test positive;
- •14.History of psychosis;
- •History of postural hypotension;
- •More than 5 cigarettes per day;
- •More than 28 units of alcohol per week; Or alcohol breath test positive within 24 hours before pre-dose;
- •History of dizziness of blood or needle;
- •Unsuitable for other reasons.
研究组 & 干预措施
GB221 group
6 mg/kg, single dose, intravenous infusion, 90-100 min
干预措施: GB221 (Drug)
Herceptin group
6 mg/kg, single dose, intravenous infusion, 90-100 min
干预措施: Herceptin (Drug)
结局指标
主要结局
AUC0-t
时间窗: Day 43
compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®
AUC0-∞
时间窗: Day 43
compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®
Cmax
时间窗: Day 43
compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®
次要结局
- ADA(Day 43)
- t1/2(Day 43)
- CL(Day 43)
- Nab(Day 43)
- Tmax(Day 43)
- Vd(Day 43)
- Ke(Day 43)