NCT07706777招募中2 期
Clinical Study on Safety and Efficacy of HRS-2129 for Acute Gouty Arthritis
Shandong Suncadia Medicine Co., Ltd.4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年8月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose
研究概览
简要总结
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring Acute gouty arthritis
- •Target joint VAS pain score ≥ 50 mm (screening)
排除标准
- •Subjects with a history of severe allergies
- •Subjects with nervous system disease
- •Subjects with a history of mental illness
- •Subjects with abnormal liver and renal function
- •Subjects with poorly controlled hypertensive
- •QTc：>450ms（male），>470ms（female）
- •History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group A: HRS-2129 Tablet
Experimental
干预措施: HRS-2129 Tablet (Drug)
Treatment group B: HRS-2129 Tablet
Experimental
干预措施: HRS-2129 Tablet (Drug)
Treatment group C: HRS-2129 Tablet Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose
时间窗: from ICF signing date to 24 hours after first dose
VAS，Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
次要结局
- Safety：Incidence and severity of AE/SAE(from ICF signing date to day 14 after last dose(14 days))
- Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose(from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose)
- Time until complete disappearance of pain in the target joint(from ICF signing date to 15 days after first dose)
- Mean daily VAS pain score change from baseline (on-treatment)(from ICF signing date to 15 days after first dose)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
HRS-2129 在膝骨关节炎患者中的 Ib 期研究膝骨关节炎中重度疼痛CTR20260112山东盛迪医药有限公司 / 上海恒瑞医药有限公司
Unknown
1 期
HRS-2129 在健康受试者中单次给药的安全性、耐受性、药代动力学、药效动力学及食物影响研究ChiCTR2400092301山东盛迪医药有限公司 / 上海恒瑞医药有限公司
招募中
1 期
Phase I Study of HRS-3005 in B-cell MalignanciesNCT07556822Jiangsu HengRui Medicine Co., Ltd.190
尚未招募
2 期
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.Uncontrolled or Resistant HypertensionNCT07708441Shandong Suncadia Medicine Co., Ltd.914
招募中
2 期
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA NephropathyNCT07582133Chengdu Suncadia Medicine Co., Ltd.380