- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07701239
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Wenzheng Xiong
- 전화번호: +86 13616029339
- 이메일: wenzheng.xiong.wx10@hengrui.com
연구 장소
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310000
- The First Affiliated Hospital , Zhejiang University School of Medicine
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수석 연구원:
- Xingjiang Hu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: PFS Group (n=42)
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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.
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실험적: AI Group (n=42)
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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peak concentration (Cmax)
기간: Days 1-267
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Days 1-267
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area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t),
기간: Days 1-267
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Days 1-267
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area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
기간: Days 1-267
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Days 1-267
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Tmax,
기간: Days 1-267
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Days 1-267
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t1/2
기간: Days 1-267
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Days 1-267
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CL/F,
기간: Days 1-267
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Days 1-267
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Vz/F.
기간: Days 1-267
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Days 1-267
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Safety and tolerability as assessed by the incidence and severity of AEs,
기간: Days 1-267
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Days 1-267
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Immunogenicity of SHR-1703 as assessed by the presence and incidence of anti-drug antibodies (ADAs) and, if applicable, neutralizing antibodies (NAbs).
기간: Days 1-267
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Days 1-267
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SHR-1703-105
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
SHR-1703 Injection에 대한 임상 시험
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Jiangsu HengRui Medicine Co., Ltd.완전한
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Guangdong Hengrui Pharmaceutical Co., Ltd모병
-
Guangdong Hengrui Pharmaceutical Co., Ltd모병
-
Guangdong Hengrui Pharmaceutical Co., Ltd모병
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Marmara University모병
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China Academy of Chinese Medical SciencesNational Natural Science Foundation of China모병