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임상시험 NCT07489482은(는) 당뇨병에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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항서제약A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection 1상 60 무작위 배정 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07489482은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 당뇨병에 대해 진행되며, 1상 중재연구으로 현재 상태는 대상자모집전입니다. 참여 신청은 2026년 3월 1일부터 가능하며, 60명의 참여자를 모집할 예정입니다. 항서제약이(가) 진행하는 이 연구는 2026년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 24일에 갱신되었습니다.
간단한 개요
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
공식 제목
A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects
질환명
당뇨병기타 연구 식별자
- SHR-3167-106
NCT 번호
실제 연구 시작일
2026-03
최신 업데이트 게시
2026-03-24
예상 연구 완료일
2026-12
계획된 등록 인원
60
연구종류
중재연구
단계/상
1상
상태
대상자모집전
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적SHR-3167 Injection - Specification A Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
실험적SHR-3167 Injection - Specification B Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
실험적SHR-3167 Injection - Specification C Group | SHR-3167 Injection SHR-3167 injection, different specifications. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The maximum plasma concentration (Cmax) | Day 1 - Day 71. | |
The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t) | Day 1 - Day 71. | |
The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞) | Day 1 - Day 71. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time to maximum plasma concentration (Tmax) | Day 1 - Day 71. | |
Terminal half-life (t1/2) | Day 1 - Day 71. | |
Apparent volume of distribution (Vz/F) | Day 1 - Day 71. | |
Safety: Incidence and severity of adverse events (AEs) | Day 1 - Day 71. | |
Anti-SHR-3167 antibody (ADA) | Day 1; Day 22; Day 71. | |
Apparent clearance (CL/F) | Day 1 - Day 71. |
참여 도우미
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
- Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
- During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
- Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.
- Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
- Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
- Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
- Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
- Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
- Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
- Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
- Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
- Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
- Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
- Persons with incomplete civil capacity and without a valid guardian.
- The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.
항서제약연구 대표 연락처
연락처: Yanli Dong, +86-0518-82342973, [email protected]
연락처: Weijie Kong, +86-0518-82342973, [email protected]
1 1개국에 임상시험 장소
Hunan
Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China
Gan Zhou, 연락처, +86-0731-89753401, [email protected]
Gan Zhou, 책임연구자