A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of adverse events including laboratory abnormality after Single Subcutaneous (SC) Injection of GX-I7
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7 in healthy volunteers.
详细描述
The subjects who are adequately eligible to attend this clinical trial via screening will be hospitalized one day prior to the injection (Day -1), administered a single dose of GX-I7 solution for subcutaneous injection, and then discharged on Day 3. After completing all scheduled tests at the visit 8 (Day 28), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 3 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 or check-in
- •History of alcohol, drug, or substance abuse in the past 12 months
- •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
- •Any other factor that the Investigator thinks will increase subject risk with participation
研究组 & 干预措施
Cohort 1
GX-I7 SC 20㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: GX-I7 (Drug)
Cohort 1
GX-I7 SC 20㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: Placebo (Drug)
Cohort 2
GX-I7 SC 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: GX-I7 (Drug)
Cohort 2
GX-I7 SC 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: Placebo (Drug)
Cohort 3
GX-I7 IM 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: GX-I7 (Drug)
Cohort 3
GX-I7 IM 60㎍/㎏ (8 subjects) / Placebo (2 subjects)
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of adverse events including laboratory abnormality after Single Subcutaneous (SC) Injection of GX-I7
时间窗: 4 weeks
Adverse events after injections.
次要结局
- Pharmacokinetic (PK) Assessment: Time to Cmax (Tmax)(4 weeks)
- Pharmacokinetic (PK) Assessment: Area under the curve from zero to infinity (AUC(0-inf))(4 weeks)
- Pharmacodynamic (PD) Assessment: Area Under The Effect-Time Curve Up To Last Quantifiable Effect (AUEClast) of ALC(8 weeks)
- Pharmacokinetic (PK) Assessment: Maximum serum concentration (Cmax)(4 weeks)
- Pharmacokinetic (PK) Assessment: Area under the curve from zero to last time of measurable concentration after single administration by trapezoidal rule (AUCt)(4 weeks)
- Pharmacokinetic (PK) Assessment: apparent terminal half-life (t1/2)(4 weeks)
- Pharmacodynamic (PD) Assessment: Emax of Absolute Lymphocyte Count (ALC)(8 weeks)