Език: EN EN
← Назад към резултатите
Набира участници Фаза 1 NCT07032688

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Type 2 Diabetes

Спонсор: Jiangsu HengRui Medicine Co., Ltd.

Налично на: БГ
Обобщение
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
Кой може да участва
Inclusion Criteria: 1. Informed consent obtained before any trial-related activities. 2. Age 18\~59 years at screening (including cut-off values at both ends). 3. Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening. 4. Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating. Exclusion Criteria: 1. Poor blood pressure control at screening. 2. Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods. 3. Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening. 4. Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection. 5. Malignancy or history of malignancy within 5 years prior to screening. 6. Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening. 7. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Интервенции
SHR-3167 Injection
DRUG
Insulin Degludec Injection
DRUG
Места на провеждане 1
Китай (1)
West China Hospital of Sichuan University
Chengdu , Sichuan
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
59 Years
Здрави доброволци
Не
Начална дата
11.08.2025
Крайна дата
01.04.2027
Регистрационен номер
NCT07032688
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.