A Phase I, Single-arm, Open-label, Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Absolute number of subjects experiencing treatment-related adverse events in each cohort
研究概览
简要总结
This Phase I clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers.
详细描述
This Phase I, single-arm, open-label, dose-escalation clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers. The study aims to:
- Determine the frequency and severity of treatment-related adverse events, adverse events leading to discontinuation, and serious adverse events (SAEs) within each cohort.
- Assess the effects of Orialpha on hematology and biochemistry parameters before dosing and after the final dose in each cohort.
Healthy volunteers who meet all eligibility criteria will receive the investigational product for 7 days. The first cohort will include 3 participants receiving the lowest dose (0.25 × the anticipated clinical dose). Following safety evaluation, subsequent cohorts will receive higher dose levels (0.5 ×, 1.0 ×, 1.5 ×, and 2.0 × the anticipated clinical dose) according to predefined dose-escalation rules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding is performed. This is an open-label study in which participants, investigators, and study staff are aware of the investigational product being administered.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, aged 18 to 60 years.
- •No clinically significant abnormalities in hematology, biochemistry, electrocardiogram (ECG), or vital signs as assessed by the investigator.
- •Willing to voluntarily participate in the study by signing the informed consent form.
- •Able to comply with study procedures and treatment as assessed by the investigator.
排除标准
- •History of allergy to herbal-derived drugs similar to the investigational product or any excipient.
- •Current or prior participation in another clinical trial involving an investigational product within the past 4 months.
- •Use of immunosuppressive drugs within 28 days prior to the first dose of Orialpha.
- •Active autoimmune disease or documented history of autoimmune disease within the past 2 years.
- •History of primary immunodeficiency.
- •Presence of any acute or chronic illness requiring treatment.
- •Inability to comply with study procedures or investigational product administration as assessed by the investigator.
- •Female subjects who are pregnant or breastfeeding, or male or female subjects of reproductive potential not using effective contraception.
- •Any condition which, in the opinion of the investigator, would interfere with the evaluation of the investigational treatment, patient safety, or interpretation of study results
结局指标
主要结局
Absolute number of subjects experiencing treatment-related adverse events in each cohort
时间窗: From the first dose administration until the final study visit (up to 90 days).
Percentage (%) is calculated as the absolute number of treatment-related adverse events divided by the total number of subjects in the SS.
Absolute number of subjects experiencing adverse events leading to study discontinuation in each cohort
时间窗: From the first dose administration until the final study visit (up to 90 days)
Percentage (%) is calculated as the absolute number of adverse events leading to discontinuation divided by the total number of subjects in the SS.
Absolute number of subjects experiencing serious adverse events (SAEs) in each cohort
时间窗: From the first dose administration until the final study visit (up to 90 days).
Percentage (%) is calculated as the absolute number of SAEs divided by the total number of subjects in the SS
次要结局
- Biochemistry and hematology test values (quantitative variables) before and after the study(Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart)