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Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers

NCT02359877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-10

Study results available
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Summary

This is an international multicenter study of tolerability, pharmacokinetics and pharmacodynamics of drug product BCD-054 (CJSC BIOCAD, Russia), administrated intramuscular and subcutaneous, compared to Rebif® (Merck Serono S.p.A., Italy) and Avonex® (Biogen Idec Ltd, UK) in healthy volunteers. The study involves 2 stages - single ascending dose administration and multiple estimated therapeutic dose administration of BCD-054.

Conditions

  • Healthy

Interventions

DRUG

BCD-054

DRUG

Rebif

DRUG

Avonex

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Ivan Sardaryan, PhD · OOO BioEk

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Russia

Study Locations

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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 NCT02359877 on ClinicalTrials.gov