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

NCT07032688 | Recruiting Phase 1

• 1 other identifier: SHR-3167-103
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).

  From 0 to 168 hours after SHR-3167 administration.

Secondary Outcomes (3)

• Maximum observed SHR-3167 concentration (Cmax, ss).

  From 0 to 168 hours after SHR-3167 administration.

• Adverse events (AEs).

  21 weeks to 43 weeks.

• Hypoglycemic events.

  21 weeks to 43 weeks.

Study Arms (1)

SHR-3167 Group

EXPERIMENTAL

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

Interventions

SHR-3167 Injection DRUG

SHR-3167 injection.

SHR-3167 Group

Insulin Degludec Injection DRUG

Insulin Degludec injection.

SHR-3167 Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 200433, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Han Jianting

CONTACT

+86-0518-82342973; jianting.han.jh27@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)