Autoimmune diseases
Conditions
Interventions
Group T:T,40mg/0.8mL
Group R:R,40mg/0.8mL
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) a full informed of the purpose of the experiment and a basic understanding of the pharmacological effects and possible adverse reactions of the drugs studied; Voluntary signing of written informed consent; 2) healthy male subjects aged 18 and 45; 3) body weight 50 kg and 80 kg, body mass index (BMI) 19 and 26kg/m2; 4) confirm the health of subjects through screening period related examination and diagnosis including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and chest X-ray; 5) the results of clinical laboratory examination are normal, or abnormal results have no clinical significance after the judgment of the researcher; 6) blood pressure on screening visit and admission day: systolic blood pressure 140mmHg 90mmHg, diastolic blood pressure 90mmHg 60mmHg; 7) subjects and partners have no pregnancy plan within 1 year after informed consent, and they all agree to use reliable contraceptive measures (such as abstinence, sterilization, contraceptive, progesterone injection or subcutaneous implantation) during the study period and within 6 months after the injection of the study drug.
Exclusion criteria
Exclusion criteria: 1) clinical significance of proteinuria test or history of proteinuria assessed by the investigator; 2) have a clear history of blood, central nervous system, cardiovascular system, liver and kidney, digestive system, respiratory system, endocrine and metabolic system (including known diabetes) or other important diseases; 3) previous definite history of neurological or mental disorders (including epilepsy or dementia), moderate to severe cardiac failure, immune deficiency or autoimmune diseases; 4) have a family history of cancer, or have had malignant tumor or present history of malignant tumor in the past 5 years, excluding the resected non-melanoma skin cancer; Or any abnormality of tumor markers has clinical significance; 5) have used any biological products or received live vaccines within 3 months before using the study drugs; 6) bacterial, viral, systemic fungal, parasitic or other opportunistic infections within 30 days before the use of the study drug; 7) previous TB history, or active TB, latent TB infection, or -interferon release test (IGRA) positive; 8) those who have used adamab or its analogues or anti-drug antibodies to detect positive; 9) any result of anti-nuclear antibody (ANA) or anti-double-stranded DNA antibody is positive; 10) use prescription or non-prescription drugs or nutritional supplements within the 5 half-life of the drug or nutritional supplements or within 2 weeks before the use of the study drug (the time limit is longer). Herbal health products should be discontinued 28 days before the use of the study drug. 11) hepatitis b virus surface antigen (HBsAg), peripheral blood hepatitis b virus deoxyribonucleic acid (DNA) quantitative detection of > normal upper limit, hepatitis c virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody, any positive; 12) have or are currently suffering from clinically significant atopic allergies, hypersensitivity reactions or allergic reactions, including known or suspected allergies to adamzumab or ingredients, excipients or latex related to the test drug; 13) those who have a history of blood donation 3 months before the use of the study drug, or who have received major surgery within the first 6 months randomly; 14) have received any other study drug treatment including biological products or participated in another interventional clinical trial within 3 months prior to the use of the study drug; 15) the subjects smoked more than 5 cigarettes/day on average before the test; Or the subject cannot promise to quit smoking within 72 hours prior to administration and during hospitalization; Smoking more than 5 cigarettes/day on average from discharge to the end of the test; 16) have a history of drug abuse or abuse; Or positive drug screening results; Or cannot guarantee not to abuse drugs during the study period; 17) have a history of alcohol abuse (consuming more than 14 units of alcohol per week [1 unit =285ml beer =25ml spirit =80ml wine]); Or alcohol breath test positive within 24 hours before administration; Or the subject is unable to promise to abstain from alcohol within 72 hours prior to administration and during hospitalization; 18) the study cannot be completed in accordance with the program requirements during the study period; 19) situations that other researchers consider unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed