A Dose-escalation, Single-center, Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles of VV116 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
- 38
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK characteristics. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained. The dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.
详细描述
4 subjects in the 25 mg dose group will receive VV116 tablets and the other 2 subjects will receive placebo. In other dose groups, 6 subjects in each group will receive VV116 tablets and 2 subjects will receive placebo. 25mg,800mg and 1200 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).
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;
- •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
Subjects will receive VV116 orally for single dose.
干预措施: VV116 25mg Group (Drug)
VV116
Subjects will receive VV116 orally for single dose.
干预措施: VV116 200mg Group (Drug)
VV116
Subjects will receive VV116 orally for single dose.
干预措施: VV116 400mg Group (Drug)
VV116
Subjects will receive VV116 orally for single dose.
干预措施: VV116 800mg Group (Drug)
VV116
Subjects will receive VV116 orally for single dose.
干预措施: VV116 1200mg Group (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: VV116 25mg Group (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: VV116 200mg Group (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: VV116 400mg Group (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: VV116 800mg Group (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: VV116 1200mg Group (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 7 days after treatment
Incidence of Treatment-Emergent Adverse Events
Tmax
时间窗: From time zero up to 48 hours post-dose following oral administration of VV116
time at which Cmax occurs
Cmax
时间窗: From time zero up to 48 hours post-dose following oral administration of VV116
maximum observed plasma concentration
AUC0-∞
时间窗: From time zero up to 48 hours post-dose following oral administration of VV116
area under the plasma concentration-time curve from time zero to infinity
AUC0~t
时间窗: From time zero up to 48 hours post-dose following oral administration of VV116
area under the plasma concentration time curve from time zero to the last measurable concentration
次要结局
- Cumulative excretion and percentage of VV116 and major metabolites in feces.(From time zero up to 72 hours post-dose following oral administration of VV116)
- structural of metabolites(From time zero up to 72 hours post-dose following oral administration of VV116)
- Ae(total excretion of kidney)(From time zero up to 72 hours post-dose following oral administration of VV116)
- Ae%(proportion of excretion of kidney)(From time zero up to 72 hours post-dose following oral administration of VV116)
- CLr(renal clearance rate)(From time zero up to 72 hours post-dose following oral administration of VV116)