Phase I Study to Evaluate Single and Multiple Oral Doses of HW281171 Tablets in Healthy Participants
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Oral Administration and Dose Escalation of HW281171 Tablets in Healthy Participants
This phase 1 study aims to evaluate the safety, tolerability and pharmacokinetic profiles of HW281171 in healthy Participants. The study consists of three parts: Part A (Single-Dose Escalation Study), Part B (Food Effect and Metabolite Study), and Part C (Multiple-Dose Escalation Study).
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Lifei Liu
- 电话号码:+86-27-87173753
- 邮箱:liulifei@renfu.com.cn
学习地点
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Shanghai、中国
- Huashan Hospital, Fudan University
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接触:
- Jing Zhang
- 电话号码:+86-21-52887926
- 邮箱:Zhangj_fudan@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants sign the informed consent form prior to the initiation of any study procedures.
- Healthy male and female participants aged 18 to 45 years (inclusive), with no less than 3 participants of a single gender.
- Female participants have a body weight of ≥45.00 kg, male participants have a body weight of ≥50.00 kg, and the body mass index (BMI) ranges from 19.0 to 26.0 kg/m^2 (inclusive).
- Participants whose vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, abdominal B-ultrasound and posteroanterior chest X-ray results at screening or on Day -1 are judged by the Investigator to be normal or abnormal without clinical significance.
- Participants agree to have no fertility plan and no sperm/egg donation plan from the time of signing the informed consent form until 3 months after study withdrawal, and are willing to practice abstinence or use highly effective contraceptive methods during this period.
- Participants can communicate well with the Investigator, understand and comply with all requirements of this study, and fully understand the study purpose, nature, methods and potential Adverse Events.
Exclusion Criteria:
- Participants with a history of drug or food allergy, allergic diseases, or allergic diathesis (allergic to two or more substances), or with confirmed allergy to any component or analogue of the investigational product.
- Participants with any past or current clinically significant severe or chronic diseases of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, psychiatric systems or metabolic disorders, or any other diseases judged by the investigator that may interfere with trial results.
- Participants with a history of gastrointestinal, hepatic or renal diseases affecting drug absorption or metabolism, or known or suspected diseases affecting drug intake, transport, absorption, distribution, metabolism or excretion; participants who have undergone surgeries affecting drug absorption or metabolism (appendectomy excluded).
- Participants with abnormal examination results specified in the protocol at screening or on Day -1.
- Participants with a history of drug abuse, drug dependence, or positive drug screening results.
- Participants with positive results for any of human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, or treponema pallidum specific antibody.
- Female participants who are pregnant, lactating at screening or during the trial, or have a pregnancy test result above the upper limit of normal, or have had unprotected sexual intercourse within 2 weeks before screening.
- Participants with prior or concomitant medications/non-drug interventions specified in the protocol.
- Participants who have participated in any clinical trial of drugs or medical devices within 90 days before screening (participation in a clinical trial is defined as receiving or using the investigational drug/device).
- Participants with severe trauma or surgical operation within 3 months before screening; participants who plan to receive surgery during the trial or within two weeks after trial completion.
- Participants who have donated blood or experienced a total blood loss of ≥400 ml within 3 months before the first dose.
- Participants with difficult venous access and intolerance to venipuncture.
- Participants with a smoking history within 3 months before screening (average daily consumption >5 cigarettes), or who cannot stop using any tobacco products during the trial.
- Participants with an average weekly alcohol intake of more than 14 alcohol units within 3 months before screening (1 alcohol unit is approximately 360 ml beer, or 45 ml spirits with 40 Percentage alcohol content, or 150 ml wine), or positive alcohol breath test, or who cannot abstain from alcohol during the trial.
- Participants consuming excessive tea, coffee or caffeinated beverages on average every day (more than 8 cups, 1 cup = 250 ml) within 48 hours before the first dose, or who cannot stop consuming tea, coffee or caffeinated beverages during the trial; participants who have consumed special diets within 48 hours before the first dose (including pitaya, mango, lime, pomelo, carambola, orange, grapefruit or grapefruit products and other fruits or corresponding juices that may affect drug metabolism), or other special diets affecting drug absorption, distribution, metabolism or excretion.
- Participants with special dietary requirements and unable to follow the unified diet.
- Participants with other factors judged by the investigator to be unsuitable for participating in the clinical trial.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Part A:HW281171
Single dose of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
|
安慰剂比较:Part A:Placebo
Single dose of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
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实验性的:Part B:Sequence A
Single dose of HW281171 tablets under fasting-fed sequence |
Administered orally daily at pre-specified dose and frequency. |
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实验性的:Part B:Sequence B
Single dose of HW281171 tablets under fed-fasting sequence |
Administered orally daily at pre-specified dose and frequency. |
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实验性的:Part C:HW281171
Multiple doses of HW281171 tablets |
Administered orally daily at pre-specified dose and frequency. |
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安慰剂比较:Part C:Placebo
Multiple doses of Placebo tablets |
Administered orally daily at pre-specified dose and frequency. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The number and severity of treatment emergent adverse events (TEAEs)
大体时间:Up to 1 month
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To assess the safety and tolerability of single or multiple doses of HW281171 tablets in healthy participants. |
Up to 1 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The maximum serum concentration (Cmax)
大体时间:Up to 1 month
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Pharmacokinetic parameter |
Up to 1 month
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The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
大体时间:Up to 1 month
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Pharmacokinetic parameter |
Up to 1 month
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The time to reach Cmax (Tmax)
大体时间:Up to 1 month
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Pharmacokinetic parameter |
Up to 1 month
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The Half life (t1/2)
大体时间:Up to 1 month
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Pharmacokinetic parameter |
Up to 1 month
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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