NCT07701239尚未招募1 期
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
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PFS Group (n=42)
Experimental
干预措施: SHR-1703 Injection (Drug)
AI Group (n=42)
Experimental
干预措施: SHR-1703 Injection (Drug)
结局指标
主要结局
area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
时间窗: Days 1-267
area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
时间窗: Days 1-267
peak concentration (Cmax)
时间窗: Days 1-267
次要结局
- Tmax,(Days 1-267)
- t1/2(Days 1-267)
- CL/F,(Days 1-267)
- Vz/F.(Days 1-267)
- Safety and tolerability as assessed by the incidence and severity of AEs,(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).(Days 1-267)
研究者
研究点 (1)
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