A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants
A Study to Evaluate the Relative Bioavailability of SHR-1703 Injection Following Subcutaneous Administration Via a Prefilled Safety Syringe and a Prefilled Autoinjector in Healthy Participants
This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants.
A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Wenzheng Xiong
- 电话号码:+86 13616029339
- 邮箱:wenzheng.xiong.wx10@hengrui.com
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310000
- The First Affiliated Hospital , Zhejiang University School of Medicine
-
首席研究员:
- Xingjiang Hu
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Aged 18-55 years at ICF signing.
- Screening BMI 19-26 kg/m², weight 50-80 kg.
- Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray.
- Investigator-assessed absence of diseases that could significantly impact the study or pose additional health risks; stable health expected, no medical intervention needed. Clinically significant lab abnormalities may be retested within 1 week if justified; retest results determine eligibility.
- Females of childbearing potential and males with female partners of childbearing potential must avoid sperm/egg donation, have no pregnancy plan, and use appropriate contraception from ICF signing through 14 months post-last dose (see Section 13.1.2).
- No heavy smoking (<5 cigarettes/day) or alcohol abuse (≤15 g/day [e.g., 450 mL beer, 150 mL wine, or 50 mL low-alcohol liquor], ≤2×/week) within 6 months pre-screening; no drug abuse history. Negative drug screen and alcohol breath test at baseline.
Exclusion Criteria:
- AST, ALT, or bilirubin > ULN at screening/baseline.
- eGFR < 90 mL/min/1.73m² at screening/baseline.
- Clinically significant abnormal blood pressure (SBP >140 or <90 mmHg; DBP >90 or <60 mmHg) at screening/baseline.
- Positive for HBsAg, HBcAb with HBV-DNA > ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening.
- Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months).
- QTcF > 450 ms on repeated 12-lead ECG at screening/baseline.
- Participation in another drug/device clinical trial within 3 months prior to screening (defined as signed ICF and received study drug/device, or still in follow-up or within 5 half-lives of prior investigational drug, whichever is longer).
- Use of any prescription drugs, OTC drugs, or herbal medicines within 1 month prior to dosing (except routine vitamins ≤100% RDA or occasional paracetamol ≤2 g/day for ≤5 days/month), or less than 5 half-lives washout.
- Major trauma or surgery within 6 months prior to screening, or planned surgery during the study.
- Blood donation or significant blood loss (≥400 mL) within 1 month, or blood transfusion within 2 months prior to screening.
- Receipt or planned receipt of live (attenuated) vaccine within 1 month prior to dosing or during the study.
- Suspected or confirmed parasitic infection within 6 months prior to screening.
- Pregnant or breastfeeding women, or positive pregnancy test (HCG).
- Investigator or site personnel directly involved in the study.
- Any other condition deemed by the investigator to preclude study participation or increase risk to the participant.
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:PFS Group (n=42)
|
A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
|
|
实验性的:AI Group (n=42)
|
A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
peak concentration (Cmax)
大体时间:Days 1-267
|
Days 1-267
|
|
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
大体时间:Days 1-267
|
Days 1-267
|
|
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
大体时间:Days 1-267
|
Days 1-267
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Tmax,
大体时间:Days 1-267
|
Days 1-267
|
|
t1/2
大体时间:Days 1-267
|
Days 1-267
|
|
CL/F,
大体时间:Days 1-267
|
Days 1-267
|
|
Vz/F.
大体时间:Days 1-267
|
Days 1-267
|
|
Safety and tolerability as assessed by the incidence and severity of AEs,
大体时间:Days 1-267
|
Days 1-267
|
|
Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs).
大体时间:Days 1-267
|
Days 1-267
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
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
与本研究相关的术语
其他研究编号
- SHR-1703-105
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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