Type 2 diabetes
Conditions
Interventions
experimental group:Federemaglutide injection was given subcutaneously, 0.25mg each time
control group:Norhotite ? is administered subcutaneously, 0.25mg in one dose.
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Gender: male or female; 2) Age: 18-55 years old (including both sides); 3) Male weight =50.0kg, female weight =45kg, body mass index (BMI) between 19 and 26kg/m2 (BMI=Weight (kg)/height 2 (m2)), including boundary values; 4) Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Known to have a clear history of injection site (abdominal periumbilical) reaction, a history of severe specific allergic reactions, or known to be allergic to the investigational drug (including its formulation ingredients) or drugs of the same variety, and judged by the researcher should not be included; 2) Known to have any clinically serious disease history or currently suffering from any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, blood, respiratory, skin, neurological, gynecological and metabolic disorders and malignant tumor diseases; 3) Have a history of diabetes or family history (within a first-degree relative, that is, parents or siblings, the same); 4) Have a history of chronic or idiopathic acute pancreatitis; 5) Patients with a known history of severe chronic gastrointestinal disease, including inflammatory bowel disease, irritable bowel syndrome, or celiac disease, or who have undergone gastrointestinal surgery (except appendectomy and cholecystectomy) within 3 months prior to screening, are assessed by the investigator as unsuitable for participation in this clinical study; 6) Known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine tumor syndrome type 2; 7) Symptoms of dermatitis or skin abnormalities in and around the administration site; 8) When screening, any abnormal examination meeting the following criteria and judged by the investigator to be clinically significant: ? HbA1c =6.0%; ? Serum amylase or lipase > Upper limit of normal value; ? Serum calcitonin > Upper limit of normal value; ? Patients with clinically significant abnormalities in vital signs, physical examination, electrocardiogram, blood routine, blood biochemistry and other laboratory tests; 9) Those who test positive for hepatitis B surface antigen or hepatitis C antibody or HIV antibody or syphilis; 10) Positive urine drug screening or positive alcohol breath test at baseline visit; 11) People who have received human glucagon-like peptide-1 drugs (GLP-1) (e.g. Liraglutide, exenatide, Duraglutide, lisenatide, Benarutide, losenatide, semaglutide) and other drugs in the same class within 6 months prior to screening or who have used any other drugs (including Chinese medicines, over-the-counter drugs, vaccines, etc.) within 2 weeks prior to screening; 12) Have a history of drug abuse; 13) Smokers who smoked more than 5 cigarettes or equivalent tobacco per day in the 3 months prior to the first dose or who were unable to quit during the trial period; 14) drank more than 7 drinks per week for women or 14 drinks per week for men (1 drink =5 ounces (150mL) of wine =12 ounces (360mL) of beer =1.5 ounces (45mL) of spirits) in the 14 days prior to first dosing, or consumed any alcoholic product in the 48 hours prior to first dosing; 15) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =200ml) per day in the 14 days prior to the first dose, or tea, coffee and/or caffeinated beverages in the 48 hours prior to the first dose; 16) People who have consumed grapefruit or food or drink containing its ingredients in the 14 days prior to the first dosing; 17) Patients who cannot tolerate venipunction, have a history of needle fainting or blood fainting; 18) Patients who have participated in other clinical trials and used drugs within 3 months before the first dose; 19) A history of blood loss or donation within 3 months prior to the first do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma smeaglutide;Anti-smerglutide antibody;Cmax;AUC0-8;AUC0-t; | — |
Countries
China
Contacts
Public ContactFang Pingfei
The Second Xiangya Hospital of Central South University
Outcome results
None listed