Phase I Study GX-G3 in Healthy Subjects (GX-G3)
A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects
研究概览
地位
条件
详细说明
MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation.
The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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-
Daejeon
-
Jung-gu、Daejeon、大韩民国、301-721
- Chungnam National University Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects may be entered in the study only if they meet all of the following criteria:
- Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
- Healthy male volunteers aged 20-45 years;
- Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2;
- Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);
Exclusion Criteria:
Subjects presenting with any of the following will not be entered in to the study:
- Have a history of or current evidence of disease;
- Have percent of white blood cell (WBC) or neutrophil > UNL;
- Have count of platelet < 100,000/mm3;
- Have the longest length of spleen > 16 cm measured by abdomen ultrasonography ;
- Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes)
- Have clinically significant arrhythmia by EKG/ECG;
- Are positive for HBV, HCV, HIV;
- Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;
- Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;
- Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;
- Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;
- Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;
- Have a history of G-CSF treatment;
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Cohort 1
GX-G3 12.5 μg/kg or Placebo
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Single SC injection
其他名称:
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实验性的:Cohort 2
GX-G3 25 μg/kg or Placebo
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Single SC injection
其他名称:
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实验性的:Cohort 3
GX-G3 50 μg/kg or Placebo
|
Single SC injection
其他名称:
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实验性的:Cohort 4
GX-G3 100 μg/kg or Placebo
|
Single SC injection
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
DLT incidence and frequency after GX-G3 single S.C. injection
大体时间:6 weeks
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[DLT criteria: CTCAE V4.03]
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6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse events incidence and frequency at each dose group after GX-G3 single injection
大体时间:6 weeks
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6 weeks
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|
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Pharmacokinetics parameters after GX-G3 single injection
大体时间:3 weeks
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AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
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3 weeks
|
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Pharmacodynamics parameters after GX-G3 single injection
大体时间:3 weeks
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Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count
|
3 weeks
|
合作者和调查者
调查人员
- 研究主任:Sang-In Yang, Ph.D、Genexine, Inc, Clinical development Department
- 首席研究员:Jae Woo Kim, M.D.、CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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