Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study
研究概览
简要总结
The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.
详细描述
This was a single center, Phase 1, open-label SAD and MAD study designed to assess safety, tolerability and PK of orally administered THR-1442 tablets in Chinese healthy adults.
Subjects were enrolled to receive 20mg THR-1442 tablet in Single dose group (20mg*1 day) and multiple dose group(20mg*7days).
Blood samples for THR-1442 plasma concentrations were collected 0h till to 48hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Be able to understand and be willing to sign informed consent and voluntarily participate in the study;
- •Chinese women or men aged 18-45 (including 18 and 45) at the time of screening;
- •Men or women who agree to effective contraception from the screening period until 30 days after the last dose in the trial; Agree to take at least one effective contraceptive measure;
- •During screening and baseline, male weight ≥ 50.0kg, female weight ≥ 45.0kg, body mass index (BMI) in the range of 19 ~ 25.0kg/m2 (including 19 and 25.0kg/m2), [BMI = weight (kg) / height 2 (M2)];
排除标准
- •According to the judgment of the site investigators, including clinical significant medical history in CNS, CV system, respiratory system, blood / hematopoietic system, gastrointestinal system, liver / kidney system，etc;
- •Subjects with specific allergic history or allergic constitution such as drugs, food and pollen, or allergic to SGLT2 inhibitors or similar drugs;
- •Alcoholics (drinking 14 units per week, each unit equivalent to 360mL beer or 150mL wine or 45mL alcohol of 40% alcohol), drug or drug dependence subjects; Smokers (smoking > 5 cigarettes per day or the same amount of other tobacco products);
- •Subjects with a history of bladder dysfunction, such as urinary incontinence, frequent urination or nocturia;
- •Blood donation within 3 months before screening, including component blood or massive blood loss (≥ 200ml), receiving blood transfusion or using blood products;
- •Subjects who used prescription drugs, traditional Chinese medicine, over-the-counter drugs (OTC), vitamins, dietary supplements or supplements (e.g. ginseng) within 4 weeks before the first administration;
- •From 7 days before the first dose to the whole study period, subjects who are unwilling or unable to guarantee to forbid by the following: no smoking, no alcohol, no caffeine containing products (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise;
- •Those who are unwilling or unable to guarantee to forbid pitaya, grapefruit, mango, carambola, fruit juice and spicy food containing the above fruits from 7 days before taking the medicine and the whole test period;
- •The subject was unable to swallow the study drug or had gastrointestinal diseases leading to absorption disorders;
- •Subjects who had participated in any drug or medical device clinical trial within 3 months before screening;
研究组 & 干预措施
THR-1442 20mg Single dose group
THR-1442 20mg Single dose group: subject will be administrated 1 dose of 20mg THR-1442 on day1, the follow up till day 7.
干预措施: THR-1442 20mg Single dose (Drug)
THR-1442 20mg Multiple dose group
THR-1442 20mg Multiple dose group: subject will be administrated THR-1442 20mg QD on Day1-Day7, the follow up till day 14.
干预措施: THR-1442 20mg Multiple dose group (Drug)
结局指标
主要结局
Collect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study
时间窗: Single dose：Baseline to day 7 ； Multiple dose：Baseline to Day14
Collect data(TEAEs including clinical AEs and lab AEs) on Day7 and Day14 to evaluate THR1442 safety and tolerability
次要结局
- Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study(Single dose：Day1-Day7； Multiple dose：Day1- Day14)
- Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study(Single dose：Day1-Day7； Multiple dose：Day1- Day14)