A Single-center, Randomized, Double-blind,Placebo-controlled Study, to Evaluate Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of LW231 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
To Evaluate the Tolerability and Pharmacokinetics of LW231 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
详细描述
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of LW231 tablets in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the initial antiviral efficacy of LW231 in CHB patients following a multiple dosing regimen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.18-55 years old male or female. 2.Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 45 kg for females and 50kg for males.
- •3.Healthy status will be defined as the absence of evidence of any active or chronic disease following a detailed medical and surgical history, concomitant drug use (including hormonal supplements), a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.
排除标准
- •Any clinically significant abnormalities in laboratory test results at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.
- •Participants who have donated over 450 mL of blood or blood products or had significant blood loss within three months prior to screening.
- •Heavy smokers (those who smoke greater than or equal to 5 or more cigarettes a day within three months prior to screening).
研究组 & 干预措施
Part A: SAD in healthy participants
Part A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants.
干预措施: LW231 tablets (Drug)
Part A: SAD in healthy participants
Part A: Single ascending doses of up to 800 mg LW231 tablets in healthy participants.
干预措施: Placebo (Drug)
Part b: MAD in healthy participants
Part B: Multiple ascending doses of up to 400 mg LW231 tablets in healthy participants. Dosages will be determined from data collected from Part A.
干预措施: LW231 tablets (Drug)
Part b: MAD in healthy participants
Part B: Multiple ascending doses of up to 400 mg LW231 tablets in healthy participants. Dosages will be determined from data collected from Part A.
干预措施: Placebo (Drug)
Part c: MAD in CHB participants (optional)
Part C: Multiple ascending doses of up to 400 mg LW231 tablets in CHB participants. Dosages will be determined from data collected from Part A and Part B.
干预措施: LW231 tablets (Drug)
Part c: MAD in CHB participants (optional)
Part C: Multiple ascending doses of up to 400 mg LW231 tablets in CHB participants. Dosages will be determined from data collected from Part A and Part B.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 4 days for SAD, up to 3 days after the last dose of study drug for MAD
An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product (including investigational drug) during the course of a clinical investigation. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease that was temporally associated with the use of the investigational product, regardless of whether it was considered to be related to the investigational product or not.
次要结局
- Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of LW231(Up to 4 days after the last dose of study drug)
- Half-life (t1/2) of LW231(Up to 4 days after the last dose of study drug)
- Area Under the Curve From Time 0 to the Last Measurable Concentration (AUClast) of LW231(Up to 4 days after the last dose of study drug)
- Maximum Plasma Concentration (Cmax) of LW231(Up to 4 days after the last dose of study drug)
- Time to Cmax (Tmax) of LW231(Up to 4 days after the last dose of study drug)