Type 2 diabetes in adults
Conditions
Interventions
Group A:LY05008 (dosage 1)
Group B:TRULICITY (dosage 2)
Group C:LY05008 (dosage 3)
Group D:TRULICITY (dosage 4)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate and sign an informed consent form. 2. Healthy males, aged 18 to 45 years (including 18 and 45 years). 3. Weight>=50 kg for males, and BMI 19-26 kg/m^2. 4. No clinical significance in vital signs, physical examination, laboratory tests, 12-lead ECG and chest X-ray during the screening period. 5. Male subjects and their partners agree to use effective contraception throughout the study period and for at least 6 months after administration.
Exclusion criteria
Exclusion criteria: 1. Have suffered from any serious or chronic diseases of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology and so on; Or any disease that can interfere with the results of the test; 2. A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomas type 2 (MEN2, including MEN2A and MEN2B), or a history and clinical manifestations of acute or chronic pancreatitis, or a history of hypoglycemia or diabetes; 3. Serum calcitonin concentration exceeded the upper limit of normal value (ULN) during screening, or serum amylase concentration and serum lipase concentration exceeded either ULN; 4. The presence of clinically significant gastrointestinal diseases or medical history and surgical history (except appendectomy), such as liver and biliary diseases, gastrointestinal diseases, and gastrointestinal surgery; 5. Use the following medications or treatments before administration: (1) Use of any prescription drug within 28 days prior to administration; (2) Use of any over-the-counter medication, including health care products, within 7 days prior to administration; (3) Previous treatment with GLP-1 receptor agonists, GLP-1 analogues, or any other insulin mimicoid, or participation in trials of such drugs; 6. Had surgery within 8 weeks prior to screening or had a surgical plan prior to completion of the trial that the investigator believed would pose an unacceptable risk to the subject or might affect the study results; 7. Patients who are allergic (defined as allergic to more than two drugs or food), or who are known to be allergic to GLP-1 receptor agonists or experimental pharmaceutical ingredients; 8. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody any result positive; 9. Alcohol or tobacco users or those who tested positive for blood alcohol or were unable to ban smoking or alcohol during the study period. Alcoholism is defined as consuming more than 14 units of alcohol per week (1 unit = 350 mL beer, or 45 mL liquor, or 150 mL wine) in the 3 months prior to screening. Tobacco addiction was defined as: the average daily smoking amount in the 3 months before screening >=5 cigarettes; 10. Patients with a history of drug abuse or drug abuse, or with positive urine screening results; 11. Participated in any other clinical study involving drug intervention within 3 months prior to screening, or the drug was in the elimination period (5 half-lives) prior to screening, whichever is longer; 12. Had been vaccinated within 4 weeks prior to screening or planned to be vaccinated during the study period and within 1 month after the study; 13. Those who cannot follow a uniform diet; 14. Patients with a history of fainting blood or fainting needles; 15. Others need to be excluded, according to the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Blood anti-drug antibodies and neutralizing antibodies;Adverse events;Vital signs;Laboratory examination;Routine12-leads electrocardiogram;Physical examination; | — |
Countries
China
Contacts
Public ContactZhao Hui, Hu Wei
Drug Clinical Trial Research Center, the Second Hospital of Anhui Medical University
Outcome results
None listed