NCT05874622已完成1 期
A Randomized, Double-blind, Dose-escalating, Placebo-controlled Phase Ib Clinical Study of VC005 Tablets in Subjects With Rheumatoid Arthritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peak time in plasma(Tmax)
研究概览
简要总结
This is a randomized, double-blind, dose-escalating, placebo-controlled phase Ib clinical study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or his/her guardian understands and voluntarily signs the informed consent form (ICF);
- •The age at the time of signing the ICF is between 18 and 70 years (including borderline values), regardless of gender;
- •A body mass index [BMI = weight (kg)/height 2 (m2)] of 18 ~30 kg/m2 at the time of screening;
- •Rheumatoid arthritis diagnosed according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 rheumatoid arthritis (RA) classification criteria and at least 3 months of disease duration at the time of the screening visit;
- •A diagnosis of moderately or severely active RA;
- •Have not used any disease-modifying antirheumatic drugs (DMARDs) prior to the first dose of the trial, or have been on a stable dose of methotrexate (MTX) for ≥4 weeks prior to the first dose, or have used methotrexate, salbutamol, or a dose of a drug such as methotrexate. (SASP), chloroquine/hydroxychloroquine, gold, penicillamine, etc., but had stopped using them for ≥3 weeks before the first dose. have stopped using the drug for ≥ 3 months;
- •Subjects who have been stable on NSAIDs prior to the first dose must have had a fixed drug class and a stable dose for ≥4 weeks and continue at a stable dose for the duration of the clinical trial;
- •Subjects who have been stable on oral glucocorticoids prior to the first dose must have been stable for ≥4 weeks at a dose of ≤10 mg/day (prednisone or equivalent dose of other glucocorticoids) and continue at a stable dose for the duration of the clinical trial;
- •The subject is able to communicate well with the investigator and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •The subjects who are allergic to the study drug or any of the components of the study drug, or are allergic (multiple drug and food allergies);
- •The subjects have used any of the following medications or treatments:
- •Tyrosine kinase (JAK) inhibitor class drugs, within 1 month prior to randomization/biologic disease-modifying antirheumatic drugs (bDMARDs) within 5 half-lives prior to randomization or within 3 months,etc；
- •The subjects have a history or evidence of any of the following diseases:
- •Presence of any systemic inflammatory disease other than RA (except secondary dry syndrome)/lymphoproliferative disease, etc;
- •The presence of any abnormal laboratory test at screening that meets the following criteria (not allowed to receive within 2 weeks prior to screening) Any medical support therapy such as leukocyte boosting, anemia improvement, liver protection and enzyme reduction, blood transfusion, etc;
- •Positive hepatitis B surface antigen (HBsAg) or negative hepatitis B surface antigen, negative hepatitis B surface antibody, positive hepatitis B core antibody (HBcAb) with hepatitis B virus honeybee venom(HBV)-DNA test results above the lower limit of detection; positive hepatitis C antibody (HCVAb) with hepatitis C virus ribonucleic acid (HCV-RNA) test results above the lower limit of detection; positive syphilis spirochete antibody (TPAb) ，etc;
- •Screening period ECG corrected QT interval(QTC): > 470 ms for men and > 480 ms for women, or abnormalities of clinical significance that, in the judgment of the investigator, preclude enrollment;
- •Those with a history of substance abuse or drug use within the past five years;
- •Those who have a positive urine drug screen or alcohol screen;
- •Female patients who are planning to become pregnant or who are pregnant or breastfeeding, or who are unable to use effective contraception throughout the trial and for 6 months after the trial ends;
- •Who, for any reason, are deemed by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
VC005 Tablets High Dose groups
Experimental
干预措施: VC005 tablets (Drug)
VC005 Tablets Low Dose groups
Experimental
干预措施: VC005 tablets (Drug)
VC005 Tablets Medium Dose groups
Experimental
干预措施: VC005 tablets (Drug)
VC005 Tablets Placebo Low Dose groups
Experimental
干预措施: VC005 Tablets Placebo (Drug)
VC005 Tablets Placebo Medium Dose groups
Experimental
干预措施: VC005 Tablets Placebo (Drug)
VC005 Tablets Placebo High Dose groups
Experimental
干预措施: VC005 Tablets Placebo (Drug)
结局指标
主要结局
Peak time in plasma(Tmax)
时间窗: Day1、Day8、Day15、Day22、Day28
Peak Plasma Concentration (Cmax）
时间窗: Day1、Day8、Day15、Day22、Day28
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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