NCT07083362已完成1 期
Safety, Tolerability and Pharmacokinetic Studies of Single and Multiple Administrations of HRS-8829 in Healthy Subjects
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2025年8月6日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction（DDI）
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18 to 55 years old
- •The weight of female subjects was ≥45 kg, that of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-28.0 kg/m2
- •The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
- •Voluntarily participate in this clinical trial
排除标准
- •Have any history of allergies
- •Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc
- •The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study
- •Those who test positive for any one of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or human immunodeficiency virus antigen-antibody during the screening period
- •Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance
- •Those who have used any drugs that inhibit or induce liver enzymes within one month before administration
- •Those who have used or are currently using any medication within two weeks prior to administration
- •Those who have received a vaccine within one month prior to screening (except for the influenza vaccine) or plan to receive a vaccine during the trial period
- •Those who have undergone major surgical operations within the six months prior to screening
- •Blood donation or loss of more than 400 mL within 3 months prior to screening
- •Participate in the clinical trial of the drug as a subject and take the trial drug
- •Consumed more than 14 units of alcohol per week on average within the 3 months prior to screening
- •Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day
- •Those who consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages daily
- •Consume special food within 48 hours before administration
- •Those with a history of drug abuse
- •Those who cannot tolerate venipuncture
- •Those who have special dietary requirements
- •The researchers believe that the subjects have any other factors that make them unsuitable for participating in this trial
研究组 & 干预措施
Treatment group 1
Experimental
干预措施: HRS-8829;Placebo (Drug)
Treatment group 2
Experimental
干预措施: HRS-8829;Placebo (Drug)
Treatment group 3
Experimental
干预措施: HRS-8829;Placebo (Drug)
Treatment group 4
Experimental
干预措施: HRS-8829;Placebo (Drug)
Treatment group 5
Experimental
干预措施: HRS-8829;Edaravone injection (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: From ICF signing date to Day8 after single administration
The Incidence and severity of adverse events
时间窗: from the date of ICF signing to the 21st day after DDI administration
The incidence and severity of adverse events
时间窗: From ICF signing date to Day15 after multiple administrations
次要结局
- Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma(0 hour to 48 hour after single administration)
- Half-life (T1/2) of HRS-8829 and its metabolite in plasma(0 hour to 48 hour after single administration)
- Clearance (CL) of HRS-8829 and its metabolite in plasma(0 hour to 48 hour after single administration)
- Maximum observed concentration at steady-state of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day 16 after DDI study single-dose, plasma administrations)
- Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study single-dose, plasma administrations)
- Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study single-dose, plasma administrations)
- Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study single-dose, plasma administrations)
- Clearance (CL) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study single-dose, plasma administrations)
- Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study single-dose, plasma administrations)
- Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study multiple-dose, plasma administrations)
- Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study multiple-dose, plasma administrations)
- Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study multiple-dose, plasma administrations)
- Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone(Day1 to Day16 after DDI study multiple-dose, plasma administrations)
- Maximum observed concentration of HRS-8829 and its metabolite in plasma (Cmax)(0 hour to 48 hour after single administration)
- Cumulative amount excreted (Ae0-t) of HRS-8829 and its metabolite in urine(0 hour to 48 hour after single administration)
- Cumulative excretion fraction (Fe0-t) of HRS-8829 and its metabolite in urine(0 hour to 48 hour after single administration)
- Renal clearance (CLr) of HRS-8829 and its metabolite in urine(0 hour to 48 hour after single administration)
- Area under the serum concentration time curve (AUC) of HRS-8829 and its metabolite in plasma(0 hour to 48 hour after single administration)
- Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma(Day1 to Day15 after multiple administrations)
- Half-life (T1/2) of HRS-8829 and its metabolite in plasma(Day1 to Day15 after multiple administrations)
- Clearance (CL) of HRS-8829 and its metabolite in plasma(Day1 to Day15 after multiple administrations)
- Volume of distribution (Vz) of HRS-8829 and its metabolite in plasma(0 hour to 48 hour after single administration)
- Maximum observed concentration at steady-state of HRS-8829 and its metabolite in plasma (Cmax)(Day1 to Day15 after multiple administrations)
- Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolite in plasma(Day1 to Day15 after multiple administrations)
- Volume of distribution (Vz) of HRS-8829 and its metabolite in plasm(Day1 to Day15 after multiple administrations)
研究者
研究点 (1)
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