A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of TQH3821 in Adult Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects.
The main purpose was to evaluate the safety and tolerance of different doses of TQH3821 or in combination with methotrexate tablets after single and multiple administration in healthy subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 Sign an informed consent form before the test, and fully understand the content, process and possible adverse reactions of the test;
- •2 Be able to complete the research according to the requirements of the plan;
- •3 Subjects (including partners) are willing to voluntarily take effective contraception within 6 months from screening to the last study drug administration;
- •4 Male and female subjects aged 18 to 55 years (including critical value);
- •5 Male subjects weigh not less than 50 kg, female subjects weigh not less than 45 kg, BMI in the range of 18 ~ 28 kg / m2 (including critical value);
- •6 Physical examination, normal or abnormal vital signs are of no clinical significance
排除标准
- •1 Those who smoke more than 5 cigarettes per day in the 12 weeks before screening;
- •2 Allergic constitution (a variety of drug and food allergies);
- •3 Have a history of substance abuse, drug and/or alcohol abuse;
- •4 Donate blood or lose a lot of blood (> 450 mL) within 12 weeks prior to screening;
- •5 Take any drug that alters the activity of liver enzymes 28 days before screening, or combined with inhibitors or inducers of Cytochrome P4503A4 enzyme (CYP3A4 );
- •6 Took any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to screening;
- •7 Those who have taken a special diet or have strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion and other factors;
- •8 Those who are vaccinated with live attenuated vaccines within 28 days before the start of research treatment, inactivated vaccines within 7 days, or vaccinated during the study period;
- •9 Have taken research drugs within 12 weeks before taking our research drugs, or participated in clinical trials of drugs;
- •10 Have a history of dysphagia or any gastrointestinal diseases that affect the absorption of the drug or a history of gallbladder resection or biliary tract diseases;
- •11 Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- •12 Subjects who could not tolerate a standard meal; (only applies to subjects participating in the postprandial test);
- •13 Electrocardiogram (ECG) abnormalities have clinical significance;
- •14 Female subjects are breastfeeding during the screening period or during the test or have a positive serum pregnancy result;
- •15 Diseases with abnormal clinical significance in clinical laboratory examination or other clinical findings within 24 weeks before screening;
- •16 Positive screening for viral hepatitis (including hepatitis B and C), Acquired Immune Deficiency Syndrome (AIDS) antibodies, treponemal antibodies;
- •17 Acute illness or concomitant medication from the screening stage to the study of medication;
- •18 Chocolate, any caffeinated or xanthine-rich foods or beverages taken 24 hours before taking the study drug;
- •19 Have taken any products containing alcohol within 24 hours before taking the research medication;
- •20 Positive for urine drug screening;
- •21 Participants who were considered by the investigators to have other factors that were not suitable for this trial.
研究组 & 干预措施
TQH3821 Tablets (Single Administration Dose)
TQH3821 tablets, Single administration
干预措施: TQH3821 tablets (Drug)
TQH3821 Placebo Tablets (Single Administration Dose)
TQH3821 placebo tablets, Single administration
干预措施: TQH3821 tablets (Placebo) (Drug)
TQH3821 Tablets (Food Effect)
TQH3821 tablets, 2 sequential periods (fasting and fed)
干预措施: TQH3821 tablets (Drug)
TQH3821 Placebo Tablets (Food Effect)
TQH3821 placebo tablets, 2 sequential periods (fasting and fed)
干预措施: TQH3821 tablets (Placebo) (Drug)
TQH3821 Tablets (Multiple Administration Dose)
TQH3821 tablets once every 12 hours for 7 times during the continuous administration phase.
干预措施: TQH3821 tablets (Drug)
TQH3821 Placebo Tablets (Multiple Administration Dose)
TQH3821 placebo tablets once every 12 hours for 7 times during the continuous administration phase.
干预措施: TQH3821 tablets (Placebo) (Drug)
TQH3821 Tablets + Methotrexate Tablets
Take Methotrexate Tablets once in the first cycle, take TQH3821 Tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 Tablets + Methotrexate Tablets once in the third cycle.
干预措施: TQH3821 tablets (Drug)
TQH3821 Tablets + Methotrexate Tablets
Take Methotrexate Tablets once in the first cycle, take TQH3821 Tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 Tablets + Methotrexate Tablets once in the third cycle.
干预措施: Methotrexate tablets (Drug)
TQH3821 Placebo Tablets + Methotrexate Tablets
Take Methotrexate Tablets once in the first cycle, take TQH3821 placebo tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 placebo tablets + Methotrexate Tablets once in the third cycle.
干预措施: TQH3821 tablets (Placebo) (Drug)
TQH3821 Placebo Tablets + Methotrexate Tablets
Take Methotrexate Tablets once in the first cycle, take TQH3821 placebo tablets once every 12 hours in the second cycle for 6 times, and then TQH3821 placebo tablets + Methotrexate Tablets once in the third cycle.
干预措施: Methotrexate tablets (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: The first day of the first administration until 8 days after the last administration
Safety and tolerability are assessed by the incidence of adverse events and its severity caused by the study drug during or after dose.
次要结局
- High sensitivity C-reactive protein (hs-CRP)(Multiple Administration Dose: Blood samples were collected from 60 minutes before administration on Day 1 to 192 hours after the consecutive administration.)
- Peak concentration (Cmax)(Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.)
- Plasma concentration-area under time curve (AUC0-t)(Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.)
- Plasma concentration-area under time curve (AUC0-∞)(Pharmacokinetics blood samples were collected from 60 minutes before administration on Day 1 to 168 hours after the last administration.)