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NCT Number: NCT07032688

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

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

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 200433, China

Location status: Recruiting

Location contact

Yerong Yu

CONTACT

[email protected]

+86-028-85422982

Yerong Yu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-3167 Injection

Drug

SHR-3167 injection.

Insulin Degludec Injection

Drug

Insulin Degludec injection.

Primary outcomes

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

    Time frame: From 0 to 168 hours after SHR-3167 administration.

Secondary outcomes

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

    Time frame: From 0 to 168 hours after SHR-3167 administration.

  2. Adverse events (AEs).

    Time frame: 21 weeks to 43 weeks.

  3. Hypoglycemic events.

    Time frame: 21 weeks to 43 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Han Jianting

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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