rheumatoid arhtritis. Seropositive rheumatoid arthritis, Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention 1: a An auto-injector device of CinnoRA® (40 mg/0.8 ml) to be administered as a single subcutaneous injection. Intervention 2: a An auto-injector device of Humira® (40 mg/0.8 ml) to be ad
Treatment - Drugs
a An auto-injector device of CinnoRA® (40 mg/0.8 ml) to be administered as a single subcutaneous injection
a An auto-injector device of Humira® (40 mg/0.8 ml) to be administered as a single subcutaneous injection.
Sponsors
CinnaGen company
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Tmax 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.;T½ 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.;Volume of distribution (VD) 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.;Mean residence time (MRT). 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.;Clearance (CL). 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.;Adverse events (AE). 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: physical Examination.;AUC 0-last. 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSomayeh Amini
Orchid Pharmed Company
Outcome results
None listed