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Multiple SclerosisPhase 1NCT01500408

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

A Phase 1 study testing Interferon beta-1a (current approved manufacturing process invloving FBS) and Interferon beta-1a (new process, manufactured without FBS) in people with Multiple Sclerosis, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Interferon beta-1a (current approved manufacturing process invloving FBS) and Interferon beta-1a (new process, manufactured without FBS)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
Jan 2012to Apr 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of hypersensitivity or intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, or aspirin that would preclude use of at least 1 of these during the study.
  • Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer.
  • Treatment with any medication including over-the-counter (OTC) products within 48 hours prior to Day 1, except for the following treatments, which are allowed: contraceptives, hormone replacement therapy (HRT), local, non-systemically absorbed steroids (i.e., topical, nasal/inhaled), acetaminophen (paracetamol), ibuprofen, naproxen, and/or aspirin.
  • Female subjects who are pregnant or currently breastfeeding or have a positive pregnancy test result.
  • Vaccinations within 4 weeks prior to Day 1.
  • Blood donation (1 unit or more) within 1 month prior to Day 1.
  • Current enrollment in any other study treatment or disease study.
  • Inability to comply with study requirements.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Saint Paul, Minnesota

Other trials in United States

About this study

Official title: A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different Processes

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.

Being tested
Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS)
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Avonex®)

    Single dose of 60 mcg given Intramuscularly (IM)

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

    Single dose of 60 mcg given Intramuscularly (IM)

Study groups in NCT01500408
Study groupRoleWhat they receive
Commercial INFB followed by Investigational INFBOtherProcess A (currently-approved manufacturing process involving FBS) first, then Process B (new serum-free manufacturing process, without FBS)
Receives: Drug: Interferon beta-1a (current approved manufacturing process invloving FBS); Drug: Interferon beta-1a (new process, manufactured without FBS)
Investigational INFB followed by Commercial INFBOtherProcess B (new serum-free manufacturing process, without FBS) first, then Process A (currently-approved manufacturing process involving FBS)
Receives: Drug: Interferon beta-1a (current approved manufacturing process invloving FBS); Drug: Interferon beta-1a (new process, manufactured without FBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500408
Sponsor's protocol ID
108HV106
Status last verified
Nov 2012
First submitted
22 Dec 2011
Last updated
19 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Interferon beta-1a (current approved manufacturing process invloving FBS) and Interferon beta-1a (new process, manufactured without FBS) in people with Multiple Sclerosis, run by Biogen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve (AUC) as a measure of PK. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.

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