Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

• Status: Completed
• Trial end date: 2017-03-15
• Target enrollment: 0
• Participant gender: Male

Summary

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept.

The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.

The secondary objectives of the study are:

To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AryoGen Pharmed Co.
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Etanercept

Criteria

Inclusion Criteria:

• 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 29.9kg/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 Criteria:

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