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

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SHR-3167 Injection; Drug: Insulin Degludec Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07032688

SHR-3167-103

Details and patient eligibility

About

The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

SHR-3167 Group

Experimental group

Treatment:

Drug: Insulin Degludec Injection

Drug: SHR-3167 Injection