Clinical pharmacology study of repeated intramuscular injections of G-CSF

Department of Orthopaedic Surgery, Keio University School of Medicine0 个研究点目标入组 18 人开始时间: 2016年2月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Those who are physically and mentally sound.
•2) 20-39 years of age at the time of consent.
•3) Those who can be hospitalized from Day -1 of the study.
•4) Those who have agreed on the written informed consent.
•5) Those who are capable to comply with all study procedures and restrictions.
•6) Body weight; 50-80 kg and Body mass index (BMI); 18.5-25.0 kg/m2 at the screening examination.
•7) Systolic blood pressure ; 90 mmHg to 140 mmHg and diastolic blood pressure; <90mmHg (sitting position) at the screening examination.
•8) WBC 3,300-8,000/microL before the injection of the agent.

•1) Those who are potentially pregnant.
•2) Those who have a history of serious illnesses, or are under treatment for such illnesses.
•3) Those who have a history of drug allergies.
•4) Those who have a history of allergy to recombinant G-CSF agents.
•5) Those who have a history of excessive alcohol abuse.
•6) Smokers of cigarettes.
•7) Those who had participated in an investigational drug study within the past 4 months.
•8) Those who had used medicine within the past week.
•9) Those who had a blood donation as follows; >200ml within the past 1 week, >400ml within the past 12 weeks, or >800ml within the past year.
•10) Those who are positive for hepatitis B, hepatitis C, syphilis or HIV.
•11) Those who are determined by the principle investigator inadequate as participants for the study.

发起方

Department of Orthopaedic Surgery, Keio University School of Medicine