A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Hubei
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Wuhan、Hubei、中国、430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
- At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
- Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
Exclusion Criteria:
- Presence of clinically significant lab results at screening visit;
- Uncontrollable hypertension;
- Medical history or illness that affects your weight;
- History of diabetes;
- Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
- Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- Pre-adolescent participants (Tanner phase I);
- Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
- Surgery is planned during the tria;
- Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;
- In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Treatment group A: HRS9531 injection or Placebo
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Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
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实验性的:Treatment group B: HRS9531 injection or Placebo
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Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
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实验性的:Treatment group C: HRS9531 injection or Placebo
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Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Adverse Events (AEs)
大体时间:up to Week 28
|
up to Week 28
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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Maximum concentration (Cmax) of HRS9531
大体时间:up to Week 28
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up to Week 28
|
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Trough concentration (Ctrough) of HRS9531
大体时间:up to Week 28
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up to Week 28
|
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Area under the curve from time zero to end of dosing interval (AUC0-tau)
大体时间:up to Week 28
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up to Week 28
|
|
Changes from baseline in BMI
大体时间:up to Week 24
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up to Week 24
|
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Change from baseline in body weight
大体时间:up to Week 24
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up to Week 24
|
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Change from baseline in waist circumference
大体时间:up to Week 24
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up to Week 24
|
|
Anti-HRS9531 antibodies (ADA)
大体时间:up to Week 28
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up to Week 28
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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