Healthy volunteers needed to test how new diabetes drug enters the body
NCT ID NCT07489482
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests different doses of an experimental diabetes drug called SHR-3167 in 60 healthy adults aged 18 to 55. The goal is to measure how much of the drug gets into the blood and how safe it is, not to treat any disease. Participants will receive a single injection and be monitored for side effects and drug levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female: 18 years old to 55 years old (on the day of signing the informed consent form). 2. 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. 3. 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. 4. 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. 5. 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%. 6. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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). 5. 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. 6. 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. 7. 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. 8. Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process. 9. Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit. 10. 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. 11. Persons with incomplete civil capacity and without a valid guardian. 12. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xiangya Hospital, Central South University
RECRUITINGChangsha, Hunan, 410008, China
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