A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
详细描述
This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
The second questions are
- To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170
- To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults.
- To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults.
The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.
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
- Double (Participant, Investigator)
盲法说明
Block randomized, double-blind design controlling with IWRS
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent
- •Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2
- •Written informed consent
排除标准
- •Clinical significant medical history
- •Gastrointestinal disease or past history
- •Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs
- •Screening test AST, ALT > ULN x 1.5 Creatinine clearance < 60mL/min/1.73m2 QTcB interval > 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV)
- •SBP <90 mmHg or >150 mmHg, DBP <60 mmHg or > 100 mmHg
- •Drub abuse history
- •Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks
- •Participation in other clinical trial within 6 months
研究组 & 干预措施
SB17170 of 50mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single).
干预措施: SB17170 (Drug)
Placebo of 50mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single).
干预措施: Placebo (Drug)
SB17170 of 150mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single).
干预措施: SB17170 (Drug)
Placebo of 150mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single).
干预措施: Placebo (Drug)
SB17170 of 250mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single).
干预措施: SB17170 (Drug)
Placebo of 250mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single).
干预措施: Placebo (Drug)
SB17170 of 500mg, Single dose, Food-effect
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single).
Food-effect test for the expected efficacy dose
- 1st period without a meal
- Wash out period more than 7 days
- 2nd period with a high-fat meal
干预措施: SB17170 (Drug)
Placebo of 500mg, Single dose, Food-effect
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single).
Food-effect test for the expected efficacy dose
- 1st period without a meal
- Wash out period more than 7 days
- 2nd period with a high-fat meal
干预措施: Placebo (Drug)
SB17170 of 1000mg, Single dose
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single).
干预措施: SB17170 (Drug)
Placebo of 1000mg, Single dose
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single).
干预措施: Placebo (Drug)
SB17170 of 1500mg, Single dose
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single).
干预措施: SB17170 (Drug)
Placebo of 1500mg, Single dose
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single).
干预措施: Placebo (Drug)
SB17170 of 250mg, Multiple dose for 7days
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple).
干预措施: SB17170 (Drug)
Placebo of 250mg, Multiple dose for 7days
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple).
干预措施: Placebo (Drug)
SB17170 of 500mg, Multiple dose for 7days
Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple).
干预措施: SB17170 (Drug)
Placebo of 500mg, Multiple dose for 7days
Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple).
干预措施: Placebo (Drug)
SB17170 of 1000mg, Multiple dose for 7days
Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple).
干预措施: SB17170 (Drug)
Placebo of 1000mg, Multiple dose for 7days
Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple).
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose
Safety and Tolerability in healthy subjects
次要结局
- The area under the curve from time 0 extrapolated to infinite time(AUCinf)(Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The Area Under the Curve from dosing to the time of the last measured concentration(Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The time to reach Cmax(Tmax)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The Half life(t1/2) of SB17170 and active metabolite(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The maximum (or peak) serum concentration(Cmax)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The ratio of oral clearance(CL/F)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The Renal clearance(CLR)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The volume of distribution(vd/f)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- The ratio of unchanged drug to metabolite(Metabolic ratio)(Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour)
- Compare the concentrations of TNF-α between the active and placebo groups(Baseline 0 hour, 1.5hour, 24hour,)
- Compare the concentratiosn of Interleukin-6 between the active and placebo groups(Baseline 0 hour, 1.5hour, 24hour,)