Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects.
The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, both male and female;
- •age: 18-45 years old;
- •Weight: Male ≥ 50kg, female ≥ 45kg, 19 ≤ BMI ≤ 26 (BMI=weight (kg)/height2 (m2);
- •Subject is in generally good health according to physical examination;
- •Subjects voluntarily participate in clinical trials and sign a written informed consent form.
排除标准
- •Participated in any other clinical trial of drugs within the three months prior to the trial;
- •Any disease that may affect the safety of the clinical trial or the in vivo process of the investigational drug;
- •Allergic constitution: If there is a history of drug, food allergies, or skin allergies;
- •Any drug that inhibits or induces liver metabolism has been used within 28 days prior to the use of the investigational drug;
- •Have used any medication (including Chinese herbal medicine) and health supplements within 14 days prior to administration;
- •Have special requirements for diet and cannot follow a unified diet;
- •Subjects with a history of intolerance to venipuncture blood collection, or fear of needles and hemophobia;
- •Drinking alcohol, tea, or caffeinated beverages for a long period of time or within 48 hours prior to administration;
- •Previous alcoholics, or frequent alcohol consumption within 6 months prior to administration; or consumption of any alcohol-containing product within 24 hours prior to administration ;
- •Blood donation or blood loss (greater than 450 mL) within 3 months prior to administration, or planning to donate blood during the study period or within 3 months after the end of the study ;
- •Acute illness occurred during pre study screening or prior to administration;
- •Subjects who have any diet that can alter liver enzymes activity within 24 hours prior to administration;
- •Have undergone surgery within the first three months of screening, or plan to undergo surgery during the study period;
- •Previous drug addict and drug abuse;
- •Smoking more than 5 cigarettes per day within the first 14 days of screening, or unable to withdraw nicotine-containing products during the study;
- •Subjects who smoke or use nicotine-containing products from screening to hospitalization;
- •Abnormal and clinically significant electrocardiogram results before screening or administration, or QTcF(QTcF - Fridericia's correction formula)>450 msec;
- •Positive results of nicotine test;
- •Alcohol breath test, with test results greater than 0.0mg/100 mL;
- •Positive urine drug test at screening;
- •Pregnant or lactating women;
- •Have plan for fertility or reluctance use any contraception during the study period and within 6 months after the end of the trial;
- •Subjects with other factors that are not suitable for participation in this study as judged by the investigator.
研究组 & 干预措施
ND-003 300mg
SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
干预措施: ND-003 300mg (Drug)
ND-003 300mg
SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
干预措施: ND-003 placebo 300mg (Drug)
ND-003 40mg
SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
干预措施: ND-003 40mg (Drug)
ND-003 40mg
SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
干预措施: ND-003 placebo 40mg (Drug)
ND-003 80mg
SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
干预措施: ND-003 80mg (Drug)
ND-003 80mg
SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
干预措施: ND-003 placebo 80mg (Drug)
ND-003 160mg
SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
干预措施: ND-003 160mg (Drug)
ND-003 160mg
SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
干预措施: ND-003 placebo 160mg (Drug)
ND-003 240mg
SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
干预措施: ND-003 240mg (Drug)
ND-003 240mg
SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
干预措施: ND-003 placebo 240mg (Drug)
ND-003_Dose 1
MAD （Multiple Ascending Dose）Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_ND003_Dose 1 (Drug)
ND-003_Dose 1
MAD （Multiple Ascending Dose）Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_placebo_Dose 1 (Drug)
ND-003_Dose 2
MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_ND003_Dose 2 (Drug)
ND-003_Dose 2
MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_placebo_Dose 2 (Drug)
ND-003_Dose 3
MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_ND003_Dose 3 (Drug)
ND-003_Dose 3
MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.
干预措施: MAD_ placebo_Dose 3 (Drug)
Food effect_Cohort 1
Food effect Cohort 1: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fasting condition in day 1 and then in fed condition in day 8.
干预措施: Food effect_Cohort 1 (Drug)
Food effect_Cohort 2
Food effect Cohort 2: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fed condition in day 1 and then in fasting condition in day 8.
干预措施: Food effect_Cohort 2 (Drug)
结局指标
主要结局
Adverse Events (AE)
时间窗: through study completion, an average of 1 month
Number and type of participants with treatment-related adverse events
次要结局
- Time to maximum concentration (Tmax)(Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose)
- Clearance (CLz/F)(Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose)
- maximum concentration (Cmax)(Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose)
- Elimination Half-life (t1/2)(Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose)
- AUC from time 0 to last time of quantifiable concentration (AUC0-t)(Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose)