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

NCT01766024 | Completed Phase 1 Results

• 1 other identifier: BCD-033-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

interferon beta-1a; pharmacokinetics; pharmacodynamics; volunteers

Outcome Measures

Primary Outcomes (3)

• Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)

  Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.

  0 to 48 hours post-dose

• Cmax of Interferon Beta-1a

  Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.

  0 to 48 hours post-dose

• AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein

  Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.

  0 to 168 hours post-dose

Secondary Outcomes (10)

• Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.

  0 to 48 hours post-dose

• Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.

  0 to 48 hours post-dose

• Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.

  0 to 48 hours post-dose

• Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.

  0 to 48 hours post-dose

• Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.

  0 to 168 hours post-dose

Study Arms (2)

BCD-033 → Rebif

EXPERIMENTAL

Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.

Drug: Interferon beta-1a

Rebif → BCD-033

EXPERIMENTAL

Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.

Drug: Interferon beta-1a

Interventions

Interferon beta-1a DRUG

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.

Also known as: BCD-033, Rebif

BCD-033 → Rebif; Rebif → BCD-033

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;
• 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;
• Consent to avoid grapefruit juice (or other products containing grapefruit) intake within 72 hours before and 8 days after each administration of the study 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;
• 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 epileptic seizures;
• Intake of medications that influence immune status (cytokines and their inductors, glucocorticoids etc.) within less than 30 days before participation in the study;
• 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)

City Mariin Hospital

Saint Petersburg, 194104, Russia

Location

MeSH Terms

Interventions

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: Director of Clinical Trials
• Organization: BIOCAD

biryulin@biocad.ru

7 (812) 380 49 33

Study Officials

• Ivan Sardaryan, PhD

  City Mariin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 4, 2016
• Results First Posted: February 16, 2015

Record last verified: 2016-03

Locations

RU (1)