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Compares treatment options for Diabetes Mellitus
Official title A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection
ClinicalTrials.gov ID: NCT07489482
What this study is testing
What is SHR-3167 Injection?
SHR-3167 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy people, 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...
- Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and...
- Female people of childbearing potential or male people whose partners are of childbearing potential must have no plans for conception or sperm/egg...
- 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...
You likely can't join if
- 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...
- Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood...
- Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the...
- Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or...
- Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health...
- Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus...
See the full eligibility criteria
- Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
- For healthy people, 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...
- Female people of childbearing potential or male people 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...
- 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.
- 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...
- 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...
- 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...
- 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 people' compliance with the protocol, or prevent the people from completing the...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.