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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат SHR-1703 Injection
  A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
• Препарат SHR-1703 Injection
  A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.

Первичные конечные точки

• peak concentration (Cmax) [Срок оценки: Days 1-267]
• area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), [Срок оценки: Days 1-267]
• area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞) [Срок оценки: Days 1-267]

Вторичные конечные точки (6)

• Tmax, [Срок оценки: Days 1-267]
• t1/2 [Срок оценки: Days 1-267]
• CL/F, [Срок оценки: Days 1-267]
• Vz/F. [Срок оценки: Days 1-267]
• Safety and tolerability as assessed by the incidence and severity of AEs, [Срок оценки: 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). [Срок оценки: Days 1-267]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital ， Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07701239 · SHR-1703-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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