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A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants

2026年7月9日 更新者:Guangdong Hengrui Pharmaceutical Co., Ltd

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

介入性

注册 (估计的)

84

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

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

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:

  1. Aged 18-55 years at ICF signing.
  2. Screening BMI 19-26 kg/m², weight 50-80 kg.
  3. Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray.
  4. 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.
  5. 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).
  6. 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:

  1. AST, ALT, or bilirubin > ULN at screening/baseline.
  2. eGFR < 90 mL/min/1.73m² at screening/baseline.
  3. Clinically significant abnormal blood pressure (SBP >140 or <90 mmHg; DBP >90 or <60 mmHg) at screening/baseline.
  4. Positive for HBsAg, HBcAb with HBV-DNA > ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening.
  5. Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months).
  6. QTcF > 450 ms on repeated 12-lead ECG at screening/baseline.
  7. 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).
  8. 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.
  9. Major trauma or surgery within 6 months prior to screening, or planned surgery during the study.
  10. Blood donation or significant blood loss (≥400 mL) within 1 month, or blood transfusion within 2 months prior to screening.
  11. Receipt or planned receipt of live (attenuated) vaccine within 1 month prior to dosing or during the study.
  12. Suspected or confirmed parasitic infection within 6 months prior to screening.
  13. Pregnant or breastfeeding women, or positive pregnancy test (HCG).
  14. Investigator or site personnel directly involved in the study.
  15. Any other condition deemed by the investigator to preclude study participation or increase risk to the participant.

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: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

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7月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年7月9日

首先提交符合 QC 标准的

2026年7月9日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月9日

最后验证

2026年7月1日

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)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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