A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
2026年5月19日 更新者:Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
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.
研究概览
研究类型
介入性
注册 (估计的)
88
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
-
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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:HS-10522
|
HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
|
|
安慰剂比较:HS-10522 Placebo
|
HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
大体时间:SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
|
Safety and tolerability will be assessed by comparison of number of adverse events between groups
|
SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum plasma concentration (Cmax)
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
time to maximum plasma concentration (Tmax)
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
area under the curve (AUC)
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
half-life
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
apparent volume of distribution (Vz/F)
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
apparent oral clearance (CL/F) of HS-10522
大体时间:-0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
Plasma aldosterone following single and multiple oral doses of HS-10522
大体时间:0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
Cortisol following single and multiple oral doses of HS-10522
大体时间:0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
Metabolites levels following single and multiple oral doses of HS-10522
大体时间:0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
(Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline
大体时间:14 days after dosing
|
Blood pressure measurement will be performed only in MAD part
|
14 days after dosing
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年1月20日
研究完成 (估计的)
2027年2月3日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月19日
首次发布 (实际的)
2026年5月27日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.