NCT06514963已完成1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect on the Pharmacokinetics of HRS-9813 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety: incidence of adverse event (AE), serious adverse event (SAE)
研究概览
简要总结
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
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
- •Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- •Male or female aged 18-55 (adult healthy volunteers);
- •Body mass index (BMI) between 19 and 26 kg/m2;
- •Normal Electrocardiogram (ECG);
- •Men and women of childbearing potential must agree to take effective contraceptive methods.
排除标准
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
- •History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
- •Seated systolic blood pressure (SBP) of <90 mmHg or seated diastolic blood pressure (DBP) of <60 mmHg;
- •Patients with orthostatic hypotension;
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
研究组 & 干预措施
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
干预措施: HRS-9813 (Drug)
single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
干预措施: Placebo (Drug)
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo
干预措施: HRS-9813 (Drug)
multiple ascending dose (MAD) cohorts
Experimental
Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: incidence of adverse event (AE), serious adverse event (SAE)
时间窗: 7 days (SAD), 14 days (MAD)
次要结局
- PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)(Days 1-9)
- PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine(Days 1-2)
- PK parameter of HRS-9813: Half-life (t1/2)(Days 1-9)
- PK parameter of HRS-9813: Renal clearance (CLR)(Days 1-2)
- PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)(Days 1-9)
- PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)(Days 1-9)
- PK parameter of HRS-9813: Fractional excretion (fe) in the urine(Days 1-2)
- PK parameter of HRS-9813: Area under the concentration time curve (AUC)(Days 1-9)
- PK parameter of HRS-9813: Apparent clearance (CL/F)(Days 1-9)
- PK parameter of HRS-9813: Accumulation ratio (Racc)(Days 1-9)
研究者
研究点 (1)
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