healthy humans
Conditions
Interventions
Group 1 (GR007 low dose):GR007 30 mg, i.m.
Group 2 (GR007 moderate dose):GR007 90 mg, i.m.
Group 3 (GR007 high dose):GR007 150 mg, i.m.
Sponsors
The First Hospital of Peking University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers, aged 18~45 years old,no gender limited; 2. Weight=50 kg, BMI is 19~24kg/m2 (including critical value); 3. Based on the results of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory examination, the investigators judge the subjects are healthy, and without cardiovascular, liver, kidney, digestive tract, nervous system, mental disorders or metabolic abnormalities; Comprehensive physical examination showed no abnormal or abnormal but without clinical significance in body temperature, blood pressure, heart rate, respiratory status and various laboratory examination (based on clinical judgment); 4. Subjects are fully aware of the purpose, nature, method and possible adverse reactions of the study, and sign informed consent; 5. Subjects are able to communicate with the researchers and complete the test according to the plan.
Exclusion criteria
Exclusion criteria: 1. Subjects have any serious clinical disease history or have the medical history of circulatory system, urinary system, endocrine system, nervous system diseases or hematology, immunology, psychiatric diseases, cancer or metabolic disorders; 2. Subjects allergic to drug or food,or have medical history of allergic diseases, or have allergy physique ;or subjects allergic to this product or its formulation; 3. Subjects with active infection or antibiotic treatment; 4. Have had gastrointestinal tract, liver or kidney disease affected the absorption or metabolism of drugs; 5. Have other potential medical history or disease trends such as pneumonia, asthma, diabetes and COPD; 6. Once had a chronic infectious disease, such as tuberculosis; 7. Subjects have had a major clinical disease or surgical operation within the first 4 weeks of the administration; 8. WBC 140 mmHg, DBP 90 mmHg; HR100 bpm); 10. HIV antibody positive, or syphilis helix antibody positive,or hepatitis b surface antigen positive, or hepatitis c antibody positive; 11. Subjects have had used any liver metabolism inhibitor drug (such as SSRIs antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones and antihistamines ) or liver metabolism inducer drug(such as barbiturates, carbamazepine, phenytoin, glucocorticoids and omeprazole ) within 30 days of the administration; 12. Use any prescription, over-the-counter medicine or dietary supplements within 2 weeks before this trial; 13. Use any long-acting biological agents within 6 months before this durg administration; 14. Women in childbearing age with positive pregnancy test, lactating women, women or man in childbearing age but do not want to adopt reliable contraception during this trial and within 6 months after the end of this trial; 15. Subjects daily smoking more than 5 cigarette within 3 months before screening, or weekly alcohol consumption greater than 14 units within 6 months before screening(1 unit of alcohol equal 360ml beer or 45ml spirits with 40% alcohol or 150 ml wine); 16. Disagree with fasting grapefruit juice, tea, coffee and/or caffeinated beverages, smoke and alcohol, during the trial; 17. Subjects have drug abuse history or have had used drug such as marijuana, cocaine, amphetamines, etc. within one year before this test durg administration; 18. Participated in other clinical trials of drugs within 3 months prior to the selection; 19. Subjects have had donated blood within 3 months before this trial, or plan to donate blood within 1 month after the end of this trial; 20. Subjects have difficult to take blood from the peripheral venous; 21. Subjects who are judged that not suitable to participate in this clinical trial by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;physical examination;Clinical laboratory examination;ECG;injection site reaction;AE;pharmacokinetics; | — |
Countries
China
Contacts
Public ContactYimin Cui
The First Hospital of Peking University
Outcome results
None listed