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 | Completed Phase 1 Results

• 1 other identifier: BCD-054-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pegylated interferon beta; Volunteers

Outcome Measures

Primary Outcomes (6)

• AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a

  Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively

  0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively

• AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM

  Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration

  0 to 672 hours

• AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin

  Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively

  0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively

• AUC(0-∞), AUC(0-last) of Neopterin

  Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration

  0 to 672 hours

• Adverse Event (AE) and Serious Adverse Event (SAE) Incidence

  Stage 1

  4 weeks

• Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM

  Stage 2 BCD-054 - 180 mcg - SC/IM

  4 weeks

Study Arms (3)

BCD-054

EXPERIMENTAL

Pegylated interferon beta 1a Single doses - 60 mcg, SC/IM Single doses - 120 mcg, SC/IM Single doses - 240 mcg, SC/IM Single doses - 360 mcg, SC/IM Multiple doses - 180 mcg, SC/IM

Drug: BCD-054

Rebif

ACTIVE COMPARATOR

interferon beta 1a 44 mcg, SC, 3 times a week for 2 weeks

Drug: Rebif

Avonex

ACTIVE COMPARATOR

interferon beta 1a 30 mcg, IM, once a week for 2 weeks

Drug: Avonex

Interventions

BCD-054 DRUG

Also known as: pegylated interferon beta 1a

BCD-054

Rebif DRUG

Also known as: interferon beta 1a

Rebif

Avonex DRUG

Also known as: interferon beta 1a

Avonex

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent;
• Male gender;
• Age 18 - 45 years inclusive;
• Body mass index (BMI) (18,5 - 24,99 kg/m2);
• Healthy condition proven by the volunteer's history, global assessment and laboratory analysis results:
• Absence in past medical history and at screening of clinically significant dysfunctions of circulatory, respiratory, nervous, hematopoietic, endocrine and digestive systems, liver and kidneys;
• No history of cardiovascular diseases and diseases of the thyroid gland
• Hemodynamic parameters are within normal limits: systolic blood pressure - from 100 to 139 mmHg, diastolic blood pressure - from 60 to 90 mmHg, heart rate - from 50 to 90 bpm;
• Absence of history of chronic infection (tuberculosis) and chronic inflammation;
• Absence of HIV, hepatitis B and C virus, syphilis;
• Absence of psychiatric disorders and other conditions that can interfere with volunteer's ability to follow the study protocol, including depression;
• Well-being (in volunteer's opinion) within 30 days before participation in the study;
• Absence of history of systematic alcohol and drug abuse;
• Ability of the volunteer, in investigator's opinion, to follow the study protocol procedures and requirements;
• Consent to avoid alcohol intake within 24 hours before and 8 days after each administration of the test or reference drugs;

You may not qualify if:

• History of serious allergic reactions (anaphylaxis or multiple allergy);
• Known allergy or intolerance to interferons or any other components of study or reference drugs or pegylated proteins;
• Major surgery within 30 days before screening;
• Impossibility to install venous catheter for blood sampling (e.g. because of skin disorders at the sites of venipuncture);
• Diseases or other conditions that can interfere with the investigational drugs pharmacokinetics (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others);
• History of fever over 40°С
• History of increase in aminotransferases (ALT, AST) \> 2.5 × ULN
• History of epileptic seizures;
• Depression and/or suicidal ideas, suicide attempts in history
• Smoking more than 10 cigarettes per day;
• Subjects who consume more than 10 units of alcohol per week or who have history of alcohol abuse or evidence of drug/chemical abuse (one unit of alcohol equals ½ l \[500 ml\] of beer, one glass \[200 ml\] of wine or l shot glass \[50 ml\] of spirits);
• Previous participation in this study

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

OOO "BioEk"

Saint Petersburg, 197342, Russia

Location

MeSH Terms

Interventions

sampeginterferon beta-1a; Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Biryulin Andrey
• Organization: BIOCAD

biryulin@biocad.ru

+7812380 49 33

Study Officials

• Ivan Sardaryan, PhD

  OOO BioEk

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 10, 2015
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 10, 2017
• Results First Posted: December 23, 2016

Record last verified: 2017-04

Locations

RU (1)