Diabetes MellitusPhase 1NCT07489482
A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection
A Phase 1 study testing SHR-3167 Injection in people with Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- SHR-3167 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2026to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
- Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
- During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
- Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.
Who cannot join
- Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
- Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
- Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
- Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
- Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
- Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
Show all 12Show fewer
- Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
- Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
- Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
- Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
- Persons with incomplete civil capacity and without a valid guardian.
- The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Gan Zhou, +86-0731-89753401, zhougan77@163.com
Gan Zhou
About this study
Official title: A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- SHR-3167 Injection
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3167 InjectionDrug
SHR-3167 injection, different specifications.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3167 Injection - Specification A Group | Experimental | Not described Receives: Drug: SHR-3167 Injection |
| SHR-3167 Injection - Specification B Group | Experimental | Not described Receives: Drug: SHR-3167 Injection |
| SHR-3167 Injection - Specification C Group | Experimental | Not described Receives: Drug: SHR-3167 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Day 1 - Day 71.
The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t)
Measured: Day 1 - Day 71.
The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞)
Measured: Day 1 - Day 71.
Secondary outcomes (6)
Time to maximum plasma concentration (Tmax)
Measured: Day 1 - Day 71.
Terminal half-life (t1/2)
Measured: Day 1 - Day 71.
Apparent volume of distribution (Vz/F)
Measured: Day 1 - Day 71.
Safety: Incidence and severity of adverse events (AEs)
Measured: Day 1 - Day 71.
Anti-SHR-3167 antibody (ADA)
Measured: Day 1; Day 22; Day 71.
Apparent clearance (CL/F)
Measured: Day 1 - Day 71.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start2 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489482
- Sponsor's protocol ID
- SHR-3167-106
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided