A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection

Официальное название

A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects

Обзор

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.

Вмешательства

• Препарат SHR-3167 Injection
  SHR-3167 injection, different specifications.

Первичные конечные точки

• The maximum plasma concentration (Cmax) [Срок оценки: 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) [Срок оценки: Day 1 - Day 71.]
• The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞) [Срок оценки: Day 1 - Day 71.]

Вторичные конечные точки (6)

• Time to maximum plasma concentration (Tmax) [Срок оценки: Day 1 - Day 71.]
• Terminal half-life (t1/2) [Срок оценки: Day 1 - Day 71.]
• Apparent volume of distribution (Vz/F) [Срок оценки: Day 1 - Day 71.]
• Safety: Incidence and severity of adverse events (AEs) [Срок оценки: Day 1 - Day 71.]
• Anti-SHR-3167 antibody (ADA) [Срок оценки: Day 1; Day 22; Day 71.]
• Apparent clearance (CL/F) [Срок оценки: Day 1 - Day 71.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

• Xiangya Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT07489482 · SHR-3167-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗