Actively Recruiting
A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-17
55
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the behavior of SHR-3167, a drug being studied in people with type 2 diabetes. The study focuses on understanding how the drug is absorbed, distributed, metabolized, and its effects at steady state in adults aged 18 to 59 years who have had type 2 diabetes for at least six months. The study is sponsored by Jiangsu HengRui Medicine Co., Ltd. and is a phase 1 interventional trial. Participants will receive SHR-3167 injection, and insulin degludec injection is also involved in the study treatments. The trial will monitor the drug's concentration over time, especially measuring the area under the concentration-time curve from 0 to 168 hours after administration. Safety aspects like adverse events and hypoglycemic episodes will be recorded between weeks 21 and 43. During the study, participants will undergo various assessments, including blood tests to measure drug levels and safety monitoring for side effects. Researchers will also check for hypoglycemic events and other adverse reactions. The total participation period includes these monitoring phases, providing detailed information on how SHR-3167 acts in the body and its safety profile.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any trial-related activities.
- Age 18 to 59 years at screening.
- Confirmed diagnosis of type 2 diabetes mellitus for at least 6 months before screening.
- Female subjects of childbearing potential and their male partners agree to use effective contraception for 3 months after consent and have no plans to donate eggs or sperm.
- Female subjects of childbearing potential have a negative pregnancy test during screening and are not breastfeeding.
You will not qualify if you...
- Poor blood pressure control at screening.
- Known or suspected allergy to investigational drug products or related products, or history of multiple or severe allergies to drugs or foods.
- Serious cardiovascular or cerebrovascular diseases within 6 months before screening.
- Positive test for hepatitis B surface antigen, HIV antibody, treponema pallidum antibody, or hepatitis C antibody, or active infection.
- Malignancy or history of malignancy within 5 years before screening.
- Participation in another clinical trial with investigational drug or device within 90 days before screening.
- Any condition that may affect safety or interfere with trial results as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 43 weeks
Participants receive SHR-3167 injection and Insulin Degludec injection to evaluate pharmacokinetic and pharmacodynamic properties.
Regular visits during treatment for drug administration and monitoring
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 200433
Actively Recruiting
Research Team
H
Han Jianting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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