healthy volunteers
Conditions
Interventions
Arm 1:No
Arm 2:No
Sponsors
Peking University Peoples Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Volunteerly participate, informed consent form be signed; Between 18 and45 years old, adult, both men andwomen, difference of age be not more than 10 years; Screening examination 10 days prior to administration, body mass index (BMI) in between 19~24, body weight is in the range of 45~75kg.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; or women in childbearing age whose pregnancy test are positive; or who having a fertility, but failed or unwilling to take effective contraceptive measures during andwithin 3 months after the trial; 2. Known allergic to any components of GB242 or any drug, food or pollen; abnormality of immunoglobulin E (IgE) test; 3. known tuberculosis of latent forms of tuberculosis; 4. Drug abuse; 5. Known disease history of disease of central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases; 6. Known cancer family history; 7. Previously participation of any otherclinical trials in the recent 3 months, or use of any drugs known to damage major organs within 3 months; 8. blood donation in 3 months; 9. Previously use of any dugs, both prescrided or OTC in 14 days; 10. ALT or AST>1.5 N (N= upper limit of normal value) andCr>N; 11. Blood testing: WBC1.2 N (N= upper limit of normal value); ANC>0.8 n (n= lower limit of normal value); PLT=5 mm post 48~72 hours); positive result of nuclear antibody(ANA), double stranded DNA antibody (ds-DNA), soluble antigen antibody (ENA); positive result of anti drug antibody (ADA); 14. Know mental illness; 15. Know postural hypotension; 16. Cigarettes intake more than 5 cigarettes per day or the same amount of tobacco; 17. alcohol abuse ( more than 28 units / week(1 unit=285 ml beer or 25 ml spirits or 1 glass of wine); or positive results of alcohol breath test obtained in 24 hour; 18. Any clinical laboratory abnormality during screening; 19. Lack of ability of communication, understanding of the study andcooperation; lack of compliance or ability to follow protocol procedures; 20. Any other exclusion decision from investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC(0- t); | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC(0-inf);Tmax;Vd;Ke;t1/2;CL; | — |
Countries
China
Contacts
Public ContactYi Fang
Outcome results
None listed