The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects

Jiangsu T-Mab Biopharma Co.,Ltd1 个研究点分布在 1 个国家目标入组 26 人开始时间: 2015年9月1日最近更新: 2017年8月18日

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: 26
试验地点: 1
主要终点: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.

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: None

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

•18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
•At least 50kg weight,BMI between 19 and 25kg/m2
•No tobacco, alcohol and other bad habits
•No history of drug allergy and biological agents allergy and other allergies
•Not used biological agents and other drugs within three months before participated in this test
•Not participated in other test or donated blood within three months before participated in this test
•The medical history、physical examination、laboratory examination is normal or slightly abnormal
•Subjects can obey the clinical trial protocol
•Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.

排除标准

•History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
•History of drug allergy and biological agents allergy and other allergies
•Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
•Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
•Subjects accepted major surgery 4 weeks before drug administration
•Subjects vaccinated live vaccine 3 months before drug administration
•Subjects with the history of drug abuse 5 years before drug administration
•As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
•Clinical and laboratory examination results is abnormal and have clinical significance
•Subjects with poor compliance or have any unfavorable factors to participate in this test
•Subjects can not complete the research
•The researchers and their family members.