A Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of VV116 After Multiple Ascending Doses Administered Orally to Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent treatment-related adverse event(s)
研究概览
简要总结
This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical trial. The objective of this study is to evaluate the safety, tolerability, pharmacokinetic profiles of VV116 tablets after multiple ascending doses administered orally to Chinese healthy volunteers.
详细描述
Multiple-dose ascending design is used in the trial, VV116/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (200mg, 400mg, 600mg), investigational product is orally administrated BID for 5.5 days, the last dose is taken in D6 morning. When 7th day visit after last dose (D12) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started. 12 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 subjects between the ages of 18 and 45 years;
- •Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
- •Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
- •Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- •Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form;
排除标准
- •Subjects with hypersensitivity to VV116 or any of the excipients;
- •Subjects with allergic diseases or allergic constitution;
- •Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- •Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;
- •Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
- •Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
- •Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;
- •Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
- •Those who cannot quit smoking or drinking during the trial;
- •Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- •Abnormal and clinically significant chest radiographs (anteroposterior);
- •B ultrasound examination showed moderate to severe fatty liver;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;
- •Glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 at screening time or baseline;
- •Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) > 450 ms in men, > 470 ms in women, and/or other clinically significant abnormalities;
- •Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;
- •The investigator believes that there are other factors that are not suitable for participating in this trial.
研究组 & 干预措施
VV116 200 mg Group
VV116 200 mg Group
干预措施: VV116 200 mg Group (Drug)
VV116 400 mg Group
VV116 400 mg Group
干预措施: VV116 400mg Group (Drug)
VV116 600 mg Group
VV116 600 mg Group
干预措施: VV116 600mg Group (Drug)
Placebo
VV116 Matching placebo tablets; Multiple doses
干预措施: VV116 200 mg Group (Drug)
Placebo
VV116 Matching placebo tablets; Multiple doses
干预措施: VV116 400mg Group (Drug)
Placebo
VV116 Matching placebo tablets; Multiple doses
干预措施: VV116 600mg Group (Drug)
结局指标
主要结局
Number of participants with treatment emergent treatment-related adverse event(s)
时间窗: Dosing through follow-up call (7 days after last dose of investigational product)
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Number of participants with laboratory test findings of potential clinical importance
时间窗: Dosing through follow-up call (7 days after last dose of investigational product)
Number of participants with vital signs findings of potential clinical importance
时间窗: Dosing through follow-up call (7 days after last dose of investigational product)
Number of participants with ECG findings of potential clinical importance
时间窗: Dosing through follow-up call (7 days after last dose of investigational product)
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
次要结局
- Tmax(Calculated using concentration data collected from predose to 48 hours postdose)
- AUC0-∞(Calculated using concentration data collected from predose to 48 hours postdose)
- AUC0-T(Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.)
- Cmax(Calculated using concentration data collected from predose to 48 hours postdose)
- T1/2(Calculated using concentration data collected from predose to 48 hours postdose)