A Single-center, Randomized, Doule Blind, Placebo-controlled, Multiple Dose Escalation Phase 1b Study to Evaluate the Safety and Tolerability of Aolanti Weikang Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of multiple doses escalation of Aolanti Weikang tablets to determine the MTD in healthy volunteers
详细描述
This is a single-center, randomized, doule blind, placebo-controlled, multiple dose escalaction phase 1b study to evaluate the safety and tolerability of Aolanti Weikang tablets in healthy volunteers. Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD). The proposed dose escalaction levels is 3,6 and 8 tablets. If MTD is not established up to 8 tablets, the dose escalaction will be stopped. In each dose level, subjects will be randomly given orally Aolanti Weikang tablets or placebo tablets at a 3:1 ratio three times a day (tid) for 7 consecutive days, then will receive the Safety follow up for 14 days. No intrapatient dose-escalation is permitted.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) :≥19 and ≤26 kg/m2
- •Signed written informed consent
排除标准
- •With in 7 days of Screening, the average number of stool > 2 times/day
- •With in 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale
- •At least one clinically significant abnormality based the comprehensive examination (including vital signs, physical examination, laboratory examination and others)
- •Digestive diseases, or other diseases within 3 months that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator
- •Smoking, alcohol abuse or drug abuse with in 3 months or drinking within 48 hours before the first administration
- •History of drug or aurantium allergy
- •Concomitant medication within 2 weeks prior to drug administration or any drug being used
- •Participated in other clinical trials within 3 months before Screening
- •Major surgery/surgical therapy for any cause within 4 weeks of Screening, or scheduled surgeries within 2 weeks after the last dose of study drug
- •Subjects not agree to use adequate contraception from study entry through at least 28 days after the last dose of study drug
- •Pregnancy or nursing
- •Other conditions that unsuitable for enrollment considered by Investigator
研究组 & 干预措施
Aolanti Weikang tablets
3，6 or 8 Aolanti Weikang tablets each time,tid
干预措施: Aolanti Weikang tablets (Drug)
Placebo
3,6 or 8 tablets each time,tid
干预措施: Placebo (Other)
结局指标
主要结局
Maximum-tolerated Dose (MTD) of Aolanti Weikang tablets
时间窗: 3 weeks
Definition of MTD: the dose level at which 3 or more subjects experienced one or more dose limited toxicities
次要结局
- Number and grade of treatment-related adverse events (AEs)(3 weeks)