Comparison between AltebrelTM and Enbrel®

Phase 1

• Conditions: rheumatoid arhtritis.; Seropositive rheumatoid arthritis, Rheumatoid arthritis, unspecified; M05, M06.9

• Registration Number: IRCT2016033021315N4
• Lead Sponsor: AryoGen Pharmed Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Inclusion:
1)Provide written IC to participate in the trial and to comply with the trial procedures.
2)Take written informed consent to participate in the trial and to abide by the trial restrictions.
3)Be healthy male between the ages of 18 and 55 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.
4)Have a body mass index between 20.0 and 30 kg/m², inclusive
5)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.

Exclusion:
1.Being doubtful about their availability to complete the trial.
2.history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IMP formulation or comparable drugs.
3.Active or latent Tuberculosis or who have a history of Tuberculosis.
4.history of invasive systemic fungal infections or other opportunistic infections
5.systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
6.serious infection associated with hospitalisation and/or which required intravenous antibiotics
7.history of and/or current cardiac disease
8.Have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
9.Intake medication with a half-life > 24 h within 1 month or 5 half-lives of the medication prior to the first administration of IMP.
10.Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody. A positive test for HIV antibody.
11.History of CNS demyelinating disorders in family (MS)
12.Have a history of smoking >10 cigarettes per day

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: ELISA.;AUC infinite of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: Calculation.

Secondary Outcome Measures

Name	Time	Method
AUClast of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation.;Tmax of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation.;T½ of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation.;Volume of distribution (VD) of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation.;Clearance (CL) of etanercept. Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: calculation.;Adverse events (AE). Timepoint: 0, 6, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216, 312 and 480 hours. Method of measurement: physical Examination.