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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-59
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SHR-3167 Injection
  • Insulin Degludec Injection

Treatment groups

55 Participants
are divided into 1 treatment group