Overview
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
Eligibility
Inclusion Criteria:
- Informed consent obtained before any trial-related activities.
- Age 18~59 years at screening (including cut-off values at both ends).
- Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
- 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:
- Poor blood pressure control at screening.
- Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
- Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- 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.
- Malignancy or history of malignancy within 5 years prior to screening.
- Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening.
- Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.