NCT05879523已完成1 期
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年6月5日最近更新:
适应症
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
- 76
- 试验地点
- 1
- 主要终点
- 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-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy
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
- 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）or 18-85 (oHCM patients).
- •Body mass index (BMI) between 19 and 28 kg/m
- •Normal Electrocardiogram (ECG)
排除标准
- •History of persistent tachyarrhythmia and syncope;
- •A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
研究组 & 干预措施
HRS-1893 for single ascending dose (SAD) cohorts
Experimental
Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893
干预措施: HRS-1893 (Drug)
Placebo comparator for SAD cohorts
Placebo Comparator
Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator
干预措施: Placebo (Drug)
HRS-1893 for multiple ascending dose (MAD) cohorts
Experimental
Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts
干预措施: HRS-1893 (Drug)
结局指标
主要结局
incidence of adverse event (AE), serious adverse event (SAE)
时间窗: Start of Treatment to end of study (approximately 34 days)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Trial of HRS-9813 in Healthy VolunteersHealthy VolunteersNCT06514963Guangdong Hengrui Pharmaceutical Co., Ltd50
尚未招募
1 期
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate CancerProstate CancerNCT06062355Jiangsu HengRui Medicine Co., Ltd.9
招募中
1 期
A Phase I Study of HS-10386 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT05911464Jiangsu Hansoh Pharmaceutical Co., Ltd.248
已完成
1 期
Study of the Safety, Tolerability, Pharmacokinetic Characteristics of PA1010 in Healthy SubjectsChronic HBV InfectionNCT05468060Zhejiang Palo Alto Pharmaceuticals, Inc.80
尚未招募
1 期
Dose Escalation and Expansion Study of SYH2043 in Patients With Advanced Malignant TumorsAdvanced Malignant TumorsNCT05728541CSPC Ouyi Pharmaceutical Co., Ltd.367