A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses
2026年9月21日 更新者:Fujian Shengdi Pharmaceutical Co., Ltd.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
研究概览
研究类型
介入性
注册 (估计的)
122
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Jing He
- 电话号码:+86-0518-82342973
- 邮箱:jing.he@hengrui.com
研究联系人备份
- 姓名:Xuehu Gao
- 电话号码:+86-0518-82342973
- 邮箱:xuehu.gao@hengrui.com
学习地点
-
-
Shandong
-
Jinan、Shandong、中国、250013
- Jinan Central Hospital
-
首席研究员:
- Qing Wen
-
接触:
- Qing Wen
- 电话号码:+86-0531-55865012
- 邮箱:wenq0619@126.com
-
-
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
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
- The age range is from 18 to 55 years old (inclusive at both ends).
- Weight ≥ 50.0 kg.
- They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
Exclusion Criteria:
- During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
- Diabetes (except gestational diabetes).
- Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
- Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
- Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
- Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
- Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
- Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
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:HRS-1596 Group
HRS-1596, healthy subjects or obese subjects. |
HRS-1596. |
|
安慰剂比较:HRS-1596 Placebo Group
HRS-1596 placebo, healthy subjects or obese subjects. |
HRS-1596 placebo. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The incidence and severity of adverse events (AEs)
大体时间:Screening period up to Day 84.
|
Screening period up to Day 84.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The maximum plasma concentration (Cmax)
大体时间:Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Time to maximum plasma concentration (Tmax)
大体时间:Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Terminal half-life (t1/2)
大体时间:Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Anti-HRS-1596 Antibodies (ADAs)
大体时间:Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Fasting plasma glucose (FPG)
大体时间:Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
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9月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年9月21日
首先提交符合 QC 标准的
2026年9月21日
首次发布 (实际的)
2026年9月25日
研究记录更新
最后更新发布 (实际的)
2026年9月25日
上次提交的符合 QC 标准的更新
2026年9月21日
最后验证
2026年9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.