A Randomized, Double-blind, Placebo-Controlled, Single-Centre,Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
The study consists of 10 dose groups, 8 subjects in each group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and pharmacokinetics characteristics.
详细描述
The dose levels are planned at 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg,40 mg, 60 mg ,90 mg and 120mg. 6 subjects in each group will receive LV232 tablets and 2 subjects will receive placebo. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained.1 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.).Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.
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
- 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
- •Aged 18 to 45 years old, males or females;
- •Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;
- •Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;
- •Subjects who are willing to take effective 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 LV232 or any of the excipients;
- •Subjects with allergic diseases or allergic constitution;
- •Subjects with skin diseases or a history of skin allergies;
- •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 , or have a history of blood product use history
- •Subjects who have participated in clinical trials of other drugs within 3 months before screening;
- •Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before 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);
- •Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;
- •Subjects who can't quit smoking and drinking during the experiment;
- •Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);
- •Abnormal and clinically significant chest radiographs (anteroposterior);
- •B ultrasound examination showed moderate to severe fatty liver;
- •Pregnant or lactating woman 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
LV232
Subjects will receive LV232 orally for single dose.
干预措施: LV232 (Drug)
Placebo
Subjects will receive placebo orally for single dose.
干预措施: Placebo (Drug)
结局指标
主要结局
AUC0-t
时间窗: 48 hours after administration
area under the plasma concentration time curve from time zero to the last
Tmax
时间窗: 48 hours after administration
time at which Cmax occurs
Ke
时间窗: 48 hours after administration
elimination rate constant
CL/F
时间窗: 48 hours after administration
apparent clearance
MRT
时间窗: 48 hours after administration
mean Resident Time
BRPP
时间窗: 48 hours after administration
binding rate of plasma protein
Cmax
时间窗: 48 hours after administration
maximum observed plasma concentration
BP
时间窗: 48 hours after administration
Blood Plasma Ratio
Incidence of Treatment-Emergent Adverse Events
时间窗: 7 days after treatment
Incidence of Treatment-Emergent Adverse Events
AUC0-∞
时间窗: 48 hours after administration
area under the plasma concentration time curve from time zero to infinity
AUC0-24h
时间窗: 48 hours after administration
area under the plasma concentration time curve from time zero to 24 hours
t1/2
时间窗: 48 hours after administration
half life of elimination
Vd/F
时间窗: 48 hours after administration
apparent volume of distribution during the terminal phase
次要结局
- structural of metabolites(From time zero up to 96 hours post-dose following oral administration)
- Ae(From time zero up to 96 hours post-dose following oral administration)
- CLr(From time zero up to 72 hours post-dose following oral administration)
- Fe%(From time zero up to 96 hours post-dose following oral administration)
- Genetic polymorphisms in drug metabolism(Before administration)