NCT07230145尚未招募1 期
A Double-Blind, Randomized, Dose-Escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of single subcutaneous injection of SHR-4658 in healthy volunteers and volunteers with elevated blood pressure.
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
- •Able and willing to provide a written informed consent.
- •Blood pressure as defined in the protocol.
- •Male or female，aged 18 to 55 years (inclusive).
- •Meet the weight standard.
排除标准
- •Known history or current clinically significant disease.
- •Protocol-defined risk factors for disease.
- •Participated in clinical trials of other drugs or medical devices.
- •Pregnant or nursing women.
研究组 & 干预措施
SHR-4658 Group
Experimental
干预措施: SHR-4658 Injection. (Drug)
SHR-4658 Placebo Group
Placebo Comparator
干预措施: SHR-4658 Placebo Injection (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Approximately 16 weeks.
次要结局
- Maximum observed concentration (Cmax)(Approximately 16 weeks.)
- Area under the concentration-time curve from time 0 to the last time point (AUC0-last)(Approximately 16 weeks.)
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf)(Approximately 16 weeks.)
- Time to maximum observed concentration (Tmax)(Approximately 16 weeks.)
- Apparent clearance (CL/F)(Approximately 16 weeks.)
- Apparent volume of distribution (Vd/F)(Approximately 16 weeks.)
- Terminal elimination half-life (t1/2)(Approximately 16 weeks.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque PsoriasisNCT07051538Guangdong Hengrui Pharmaceutical Co., Ltd64
招募中
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy SubjectsOverweight or ObesityNCT06762600Fujian Shengdi Pharmaceutical Co., Ltd.103
招募中
1 期
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy PatientsEpilepsyNCT07051629Suninflam Inc72
已完成
1 期
The PK/PD Study of SHR7280 Tablets in Healthy Subjects.Healthy SubjectsNCT04554043Jiangsu HengRui Medicine Co., Ltd.118
已完成
1 期
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016Healthy VolunteersNCT04685564Suzhou Ribo Life Science Co. Ltd.32