MedTrace Logo

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

NCT01766024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-05-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Ivan Sardaryan, PhD · City Mariin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766024 on ClinicalTrials.gov