Diabetes
Conditions
Interventions
1.0mg:All accept KN056
3.0mg:The first 2 subjects were sentinels, randomized 1:1 to receive either KN056 or KN056 placebo, and at least 3 days after sentinel dosing, at the discretion of the investigator, dosing could be in
6.0mg:The first 2 subjects were sentinels, randomized 1:1 to receive either KN056 or KN056 placebo, and at least 3 days after sentinel dosing, at the discretion of the investigator, dosing could be in
12.0mg:The first 2 subjects were sentinels, randomized 1:1 to receive either KN056 or KN056 placebo, and at least 3 days after sentinel dosing, at the discretion of the investigator, dosing could be i
20.0mg:The first 2 subjects were sentinels, randomized 1:1 to receive either KN056 or KN056 placebo, and at least 3 days after sentinel dosing, at the discretion of the investigator, dosing could be i
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Healthy male or female; 2) Between the ages of 18 and 55 years (including cut-offs) at the time of signing informed consent; 3) BMI: 20.0 kg/m2 = BMI < 28 kg/m2; 4) HbA1c < 6.5%; 3.9 mmol/L = fasting blood glucose level < 7.0 mmol/L; 2h post-glucose load blood glucose < 11.1 mmol/L; 5) Able to understand and willing to comply with the clinical trial protocol to complete the trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) a prior history of chronic disease or the current presence of a systemic disease that in the judgment of the investigator is clinically significant, such as: cardiovascular, respiratory, endocrine and metabolic, urinary, digestive, hematologic, autoimmune, neurological or psychiatric disorders, bacterial or viral infections 2) history of acute or chronic pancreatitis; personal history or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2 (MEN2); history of other malignancies 3) previous history of gastrointestinal disease (e.g., esophageal reflux or gallbladder disease) or any gastrointestinal disease/surgery affecting gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, except appendectomy) or gastrointestinal disease that can be exacerbated by glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase-4 inhibitors (DPP-4i) 4) previous gallbladder stone removal or cholecystectomy; 5) hypersensitivity to the test drug and excipients or GLP-1 class drugs; 6) history of drug abuse/dependence or history of drug inhalation/injection within 1 year prior to screening (signing ICF); positive urine drug abuse screen; 7) Positive alcohol breath test result (> 0 mg/100 mL); 8) Any major surgery or surgery affecting drug absorption, distribution, metabolism, excretion within 3 months prior to screening or planned during the trial (major surgery is defined as surgery targeting intracranial, thoracic, abdominal, pelvic, or extremity organs that results in significant tissue trauma requiring long-term recovery) 9) Drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits at 40% alcohol or 150 ml of wine) within 3 months prior to screening or during the screening period, not being able to abstain from alcohol during hospitalization, and not being able to limit drinking to less than 2 units of alcohol per day during the post-discharge visit; 10) blood donation or blood loss = 300 ml within 3 months prior to screening (except for physiological blood loss in women), or planned blood donation or blood component donation during the trial or within 1 month after the end of the trial; 11) have received administration of another drug/vaccine clinical trial within 2 months prior to screening; are in another clinical trial at the time of screening 12) Received a vaccination within 14 days prior to screening or is scheduled to receive a vaccination during the clinical trial, including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, COVID-19 vaccine. 13) Use of any prescription, over-the-counter, or herbal medication (except vitamin/mineral supplements, acetaminophen, topical topicals, and contraceptives) within 14 days prior to dosing; 14) Use of GLP-1 analogs, GLP-1 receptor agonists or any other entero-insulin-related prescription preparations and other drugs that, in the opinion of the investigator, may interfere with the trial within 1 month prior to dosing 15) Physical examination, vital signs, electrocardiogram, clinical laboratory and other findings that are abnormal and clinically significant in the judgment of the investigator and that may have an impact on the evaluation of the results of this trial or may increase the risk to the subject; 16) Positive screening for infectious diseases: hepatitis (including hepatitis B and C) and positive screening for AIDS and sy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events after drug injection;AUC0-t;MRT; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADA;OGTT; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed