NCT07609875尚未招募1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 个研究点目标入组 88 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
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
- •For all participants:
- •Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
- •Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
- •At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).
排除标准
- •Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
- •Presence of orthostatic hypotension or orthostatic tachycardia at screening.
- •Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
- •Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
- •Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).
- •Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).
- •Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.
研究者
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