NCT01766024

Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers

International Multicenter Randomized Double-blind Crossover Study of Pharmacokinetics, Pharmacodynamics and Tolerability of BCD-033 (CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.А., Italy) After Single Subcutaneous Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized double-blind crossover study of pharmacokinetics, pharmacodynamics and tolerability of BCD-033 (interferon beta-1a manufactured by CJSC BIOCAD, Russia) and Rebif® (Merck Serono S.p.A.., Italy) in healthy volunteers. The purpose of the study is to demonstrate the non-inferiority of pharmacokinetics, pharmacodynamics and tolerability parameters after single subcutaneous injection. Each dtug will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Detailed description

Each dtug (BCD-033 and Rebif) will be administered to each volunteer at a dose of 44 µg as a single subcutaneous injection with an interval of at least 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Interferon beta-1a	Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-01-11
• Last updated: 2016-05-04
• Results posted: 2015-02-16

Locations

1 site across 1 country: Russia