NCT07739160尚未招募2 期
The Efficacy and Safety of HRS-4029 for the Treatment of Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2026年8月15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
- 尚未招募
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2
研究概览
简要总结
This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
- •Stroke onset within 3 hours prior to screening, and expected to receive study drug administration within 3 hours after stroke onset.
- •Clinical diagnosis of acute ischemic stroke (AIS).
- •Modified Rankin Scale (mRS) score ≤1 prior to stroke onset.
- •National Institutes of Health Stroke Scale (NIHSS) score of 6 to 25 at screening, and the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2.
排除标准
- •Intracranial hemorrhagic diseases, including but not limited to hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.;
- •Severe impairment of consciousness: NIHSS Item 1a (Level of Consciousness) score ≥ 2;
- •Concurrent other neurological/psychiatric disorders (e.g., Parkinsonism, epilepsy, severe cognitive impairment, severe depression, etc.) that render the patient uncooperative or unwilling to cooperate with physical examination, or that may affect the evaluation of outcomes.
- •Persistent systolic blood pressure ≥ 200 mmHg and/or diastolic blood pressure ≥ 110 mmHg following active antihypertensive treatment;
- •Severe hyperglycemia or hypoglycemia;
- •Any of the following within 3 months prior to enrollment: acute ST-elevation myocardial infarction , and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or hospitalization or unplanned coronary intervention due to acute coronary syndrome, myocardial infarction, or cardiac arrest; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia;
- •History of severe hepatic impairment;
- •History of severe renal insufficiency;
- •Advanced malignancy or currently undergoing antineoplastic treatment;
- •Female participants who are pregnant or breastfeeding, or female participants with a positive pregnancy test result at screening;
- •Participation in another interventional clinical trial involving an investigational drug or medical device (defined as having signed an informed consent form and received the investigational product/device) within 3 months prior to the screening visit;
- •Terminal illness with an estimated life expectancy of less than 1 year;
- •Any other condition that, in the opinion of the investigator, renders the participant inappropriate for study participation.
研究组 & 干预措施
HRS-4029 high dose
Experimental
干预措施: HRS-4029 (Drug)
HRS-4029 medium dose
Experimental
干预措施: HRS-4029 (Drug)
HRS-4029 low dose
Experimental
干预措施: HRS-4029 (Drug)
结局指标
主要结局
The Proportion of Participants With Modified Rankin Scale (mRS) Score ≤ 2
时间窗: Day 90
The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms 1. No significant disability 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5. Severe disability 6. Death.
次要结局
- The Proportion of Participants With Modified Rankin Scale (mRS) score ≤ 1(Day 90)
- Ordinal Modified Rankin Scale (mRS) Score(Day 90)
- The Infarct Volume(24 hours)
- The Proportion of Participants With Improvement of 4 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1(Day 10)
- The Proportion of Participants With a Barthel Index (BI) Score ≥ 95(Day 90)
研究者
研究点 (1)
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