NCT04283695Unknown早期 1 期
A Phase 1, Open-labeled, Single-dose, One-sequence, One-period, 3-part Study to Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Total radioactivity at feces,urine,blood to measure total recovery rate
研究概览
简要总结
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers
详细描述
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers To show ABA and Mass balance of GX-I7
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is willing and able to give informed consent after listening character of the clinical trial
- •Must be 19-45 years of age, inclusive
- •Weight 50-100kg, BMI 18-30kg/m2
- •Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
- •No clinical abnormality from ECG test
- •Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test)
排除标准
- •Suspected or confirmed malignancy, or has malignancy history
- •Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases
- •Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab
- •Are considering or scheduled to undergo any surgical or dental procedure during the study
- •Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months
- •Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases
- •Positive from urine drug screen or respiratory alcohol screen at medical screening
- •History of alcohol, drug, or substance abuse in the past 12 months
- •A heavy alchol consumer (>21 units/week, 1 unit = 10 g of pure alcohol) or Consumption of alcohol within 48 hours prior to hospitalization
- •Medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
- •Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration
- •Do not have veins suitable for cannulation or multiple venipunctures
- •Previously donate whole blood within 60 days or component blood within 14 days
- •Excessive consumption of foods containing grapefruits
- •Any other factor that the Investigator thinks will increase subject risk with participation
研究组 & 干预措施
Part 1
Experimental
IM: GX-I7 60 µg/kg IV: [14C]-GX-I7 40 µg
干预措施: GX-I7 or [14C] GX-I7 (Drug)
Part 2
Experimental
IV: [14C]-GX-I7 40 µg
干预措施: GX-I7 or [14C] GX-I7 (Drug)
Part 3
Experimental
IM: GX-I7 60 µg/kg, [14C]-GX-I7 40 µg
干预措施: GX-I7 or [14C] GX-I7 (Drug)
结局指标
主要结局
Total radioactivity at feces,urine,blood to measure total recovery rate
时间窗: 29 days
radioactivity in nCi
次要结局
未报告次要终点
研究者
Howard Lee
Professor
Seoul National University Hospital
研究点 (1)
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