Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers

NCT01500408 | Completed Phase 1

• 1 other identifier: 108HV106
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing process.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration-time curve (AUC) as a measure of PK.

  Subjects will be followed for the duration of the study, 22 days. PK samples will be taken 5 to 60 minutes prior to dosing, and post dose at hours 2, 4, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 72, 96 and 168.

Secondary Outcomes (1)

• The observed maximum (peak) serum Interferon beta-1a concentration (Cmax)

  Subjects will be followed for the duration of the study, 22 days. PK samples will be taken 5 to 60 minutes prior to dosing, and post dose at hours 2, 4, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 72, 96 and 168.

Study Arms (2)

Commercial INFB followed by Investigational INFB

OTHER

Process A (currently-approved manufacturing process involving FBS) first, then Process B (new serum-free manufacturing process, without FBS)

Drug: Interferon beta-1a (current approved manufacturing process invloving FBS); Drug: Interferon beta-1a (new process, manufactured without FBS)

Investigational INFB followed by Commercial INFB

OTHER

Process B (new serum-free manufacturing process, without FBS) first, then Process A (currently-approved manufacturing process involving FBS)

Drug: Interferon beta-1a (current approved manufacturing process invloving FBS); Drug: Interferon beta-1a (new process, manufactured without FBS)

Interventions

Interferon beta-1a (current approved manufacturing process invloving FBS) DRUG

Single dose of 60 mcg given Intramuscularly (IM)

Also known as: Avonex®)

Commercial INFB followed by Investigational INFB; Investigational INFB followed by Commercial INFB

Interferon beta-1a (new process, manufactured without FBS) DRUG

Single dose of 60 mcg given Intramuscularly (IM)

Commercial INFB followed by Investigational INFB; Investigational INFB followed by Commercial INFB

Eligibility Criteria

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

You may qualify if:

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authoriziation to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Must be healthy males or females 18 to 45 years old, inclusive, at the time of informed consent.
• Must have a body mass index (BMI) of 18.5 to 30.0 kg/ m2, inclusive, and a minimum body weight of 50.0 kg at Screening and Day-1 Baseline.
• Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

You may not qualify if:

• Known history of human immunodeficiency virus (HIV).
• Positive test result at Screening for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen \[HBcAb\] at Screening). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface anitbody \[HBsAg\], and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positiveHBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention interpretation of the hepatitis B serology panel).
• Subjects with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamos cell carcinomas of the skin that have been completely excised and are considered cured).
• History of severe allergic or anaphylactic reactions.
• Known allergy to any component of the IFN B-1a formulation, including a dry rubber allergy.
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
• History of seizure disorder or unexplained blackouts.
• History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator).
• Serious local infection (e.g., cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the Investigator, within 3 months prior to Day 1.
• History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to Screening.
• Positive testing for drugs and alcohol at Screening or baseline (Day-1).
• Alcohol use within 48 hours prior to Day 1. Subjects must be willing to restrict alcohol use throughout their participation in the study. Subjects may not consume more than 1 alcoholic beverage per day during this study where 1 alcoholic beverage is defined as ≤8 ounces of beer or ≤4 ounces of wine.
• Fever (body temperature \>38°C) or symptomatic viral or bacterial infection (including upper respiratory infection) within 1 week prior to Day 1.
• Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine that are above the upper limit of normal, any values for platelets or hemoglobin that are below the lower limit of normal, or any out of normal range values for white blood cells, serum sodium, or serum potassium.
• Any previous treatment with any interferon product, including investigational use.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Saint Paul, Minnesota, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

US (1)