SHR-3167 steady-state effects in adults with type 2 diabetes.

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

This test looks at how the new drug SHR-3167 behaves in the body and affects blood sugar control in adults with type 2 diabetes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07032688 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial measures the pharmacokinetics (PK) and pharmacodynamics (PD) of SHR-3167 at steady state in adults with type 2 diabetes. Participants will receive SHR-3167 injection, with insulin degludec used per protocol as applicable, and will have serial blood sampling for drug levels and glucose-related biomarkers. The study enrolls adults aged 18–59 with a diagnosis of type 2 diabetes for at least six months and includes active safety monitoring for adverse events and laboratory changes. The trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. and conducted at West China Hospital of Sichuan University in Chengdu.

Who should consider this trial

Good fit: Adults aged 18–59 with a confirmed diagnosis of type 2 diabetes for at least six months who meet health criteria and agree to required contraception (if applicable) are the intended participants.

Not a fit: Patients with poorly controlled blood pressure, recent serious cardiovascular or cerebrovascular disease, certain infections (such as positive hepatitis B), a history of severe drug allergies, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If SHR-3167 shows predictable PK/PD and acceptable tolerability, it could help define safe and effective dosing and support further development as a diabetes treatment.

How similar studies have performed: PK/PD studies of other glucose-lowering agents have successfully guided dosing for approved drugs, but SHR-3167 appears to be a novel compound undergoing early human steady-state testing.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Han Jianting

Conditions Type 2 Diabetes