临床试验方案【一项评估Orialpha（BD-C）在健康成年志愿者中的安全性和耐受性的I期、单臂、开放标签、剂量递增临床研究】
临床研究方案【一项评估Orialpha（BD-C）在健康成年志愿者中的安全性和耐受性的I期、单臂、开放标签、剂量递增临床研究】
研究概览
地位
条件
详细说明
这项I期、单臂、开放标签、剂量递增的临床研究旨在评估Orialpha（BD-C）在健康成年志愿者中的安全性，并确定其最大耐受剂量（MTD）。 本研究旨在：
- 确定每个队列中治疗相关不良事件、导致停药的不良事件以及严重不良事件（SAE）的发生频率和严重程度。
- 评估Orialpha在每个队列给药前和末次给药后对血液学和生化参数的影响。
符合所有资格标准的健康志愿者将接受为期7天的试验产品治疗。 第一个队列将包括3名接受最低剂量（预期临床剂量的0.25倍）的参与者。 根据预定的剂量递增规则，在安全性评估后，后续队列将接受更高剂量水平（预期临床剂量的0.5倍、1.0倍、1.5倍和2.0倍）。
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Hanoi
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Hanoi、Hanoi、越南、100000
- Hanoi Medical University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
纳入标准：
- 健康男性或女性，年龄在18至60岁之间。
- 研究者评估，血液学、生物化学、心电图（ECG）或生命体征无临床显著异常。
- 愿意通过签署知情同意书自愿参与本研究。
- 研究者评估，能够遵守研究程序和治疗。
排除标准：
- 对与研究产品相似的草药来源药物或任何辅料有过敏史。
- 目前或过去4个月内曾参与另一项涉及研究产品的临床试验。
- 在首次服用Orialpha前28天内使用过免疫抑制药物。
- 活动性自身免疫性疾病或过去2年内有记录的自身免疫性疾病史。
- 原发性免疫缺陷病史。
- 存在任何需要治疗的急性或慢性疾病。
- 研究者评估，无法遵守研究程序或研究产品给药。
- 怀孕或哺乳期的女性受试者，或未使用有效避孕措施的具有生育潜力的男性或女性受试者。
- 研究者认为可能干扰研究治疗评估、患者安全或研究结果解释的任何情况。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Dose level 1
Subjects received Orialpha 1 sachet, strength 1.5 g/sachet q.d. for 7 consecutive days as part of a Phase I dose-escalation study. The first cohort of 03 participants will be enrolled and administered the lowest dose level. If no toxicity cases are observed, a subsequent cohort of 03 participants will receive the next dose level. If one toxicity case occurs at this dose in the first cohort of 03 participants, an additional 03 subjects will be enrolled and administered the same dose. If, among these 06 participants, only one toxicity case is observed, the second dose level will be tested. If two or more toxicity cases are observed among these 06 participants, the study will be terminated. This procedure will be repeated for the subsequent dose levels. |
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily
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实验性的：Dose level 2
Subjects received Orialpha 1 sachet, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.
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Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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实验性的：Dose level 3 (anticipated therapeutic dose)
Subjects received Orialpha 2 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.
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Dosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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实验性的：Dose level 4
Subjects received Orialpha 3 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study
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Dosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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实验性的：Dose level 5
Subjects received Orialpha 4 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study
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Dosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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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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Absolute Number of Subjects Experiencing Treatment-related Adverse Events in Each Cohort
大体时间：From the first dose administration until the final study visit (up to 90 days).
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Treatment-related adverse events were defined as adverse events assessed by the investigator as having a causal relationship with the investigational product (definite, probable, possible, or unlikely).
Results are presented as the absolute number of participants experiencing at least one treatment-related adverse event within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days).
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Absolute Number of Subjects Experiencing Adverse Events Leading to Study Discontinuation in Each Cohort
大体时间：From the first dose administration until the final study visit (up to 90 days)
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Adverse events leading to study discontinuation were defined as any adverse event that resulted in permanent discontinuation of study treatment, as assessed by the investigator.
Results are presented as the absolute number of participants experiencing at least one adverse event leading to study discontinuation within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days)
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Absolute Number of Subjects Experiencing Serious Adverse Events (SAEs) in Each Cohort
大体时间：From the first dose administration until the final study visit (up to 90 days).
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Serious adverse events (SAEs) were defined in accordance with ICH E2A criteria.
Results are presented as the absolute number of participants experiencing at least one serious adverse event within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Any Changes in Biochemical and Hematological Laboratory Parameters Before and After Treatment Were Assessed to Evaluate Safety
大体时间：Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart
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Hematological and biochemical parameters at the end of the study were assessed, including: red blood cells (RBC), white blood cells (WBC), platelets, hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine The variables will be presented in a shift table with three categories: "normal," "abnormal - not clinically significant," and "abnormal - clinically significant" at both pre-study and post-study time points. A summary of laboratory parameters will be described in accordance with US FDA requirements. |
Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart
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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 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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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