Comparison between CinnoRA® and Humira®
- Conditions
- rheumatoid arhtritis.Seropositive rheumatoid arthritis, Rheumatoid arthritis, unspecifiedM05, M06.9
- Registration Number
- IRCT2015120621315N3
- Lead Sponsor
- CinnaGen company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria:
Provide written IC to participate in the trial and to comply with the trial procedures; Have given their written informed consent to participate in the trial and to abide by the trial restrictions; Be healthy male and female between the ages of 18 and 45 years (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests); Have a Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; Have Chest X-ray with no evidence of current active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist; Female subjects with child-bearing potential must agree to use a medically accepted method of contraception during the trial and one month after the end of the trial
Exclusion criteria: Being doubtful about their availability to complete the trial; Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (Multiple sclerosis), autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing); Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin; Diagnosed Active or latent Tuberculosis or have a history of Tuberculosis; History of invasive systemic fungal infections or other opportunistic infections; Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process; Serious infection which required hospitalization and/or intravenous antibiotics; History of and/or current cardiac disease; Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit; volunteers who have been receiving medication with a half-life of 24 hours or more within 4 weeks or 10 half-lives of the medication prior to investigational product administration; history of smoking 10 cigarettes per day or more
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax of adalimumab. Timepoint: 0 (prior to dosing), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 840, 1008, 1176, 1344, 1488 and 1680 hours after dosing. Method of measurement: ELISA.;AUCinf of adalimumab. Timepoint: 0 (prior to dosing), 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 840, 1008, 1176, 1344, 1488 and 1680 hours after dosing. Method of measurement: Calculation.
- Secondary Outcome Measures
Name Time Method