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Serum containing Avonex

Phase 1

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Jun 4, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Serum containing Avonex · 1 trial · 1 indication

Phase 1 1
NCT00913250A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy VolunteersMultiple Sclerosis
COMPLETED96 Analytics
PHASE1COMPLETED
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
Study duration is 72 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALSerum containing Avonex followed by serum free Avonex
Sequence 2EXPERIMENTALSerum free Avonex followed by serum containing Avonex

Interventions

NameTypeDescription
Serum containing AvonexDRUG60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15
Serum Free AvonexDRUG60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy Volunteers Exclusion Criteria: * History of severe allergic or anaphylactic reactions * History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine. * Known allergy to dry natural rubber * History of seizure disorder or unexplained blackouts * H...

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Frequently asked questions about Serum containing Avonex

What is Serum containing Avonex used for?

Serum containing Avonex is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is currently in Phase 1 clinical development. The drug is being evaluated for its bioequivalence to a serum-free formulation of Avonex, which is used to treat this condition.

Who makes Serum containing Avonex?

Serum containing Avonex is being developed by Biogen Inc., a biopharmaceutical company. Biogen's stock is traded under the ticker symbol BIIB on the NASDAQ exchange. The company is conducting clinical trials to evaluate this drug for the treatment of Multiple Sclerosis.

What phase is Serum containing Avonex in?

Serum containing Avonex is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its bioequivalence to a serum-free version of Avonex for the treatment of Multiple Sclerosis.

What clinical trials is Serum containing Avonex in?

Serum containing Avonex has one completed clinical trial registered under NCT00913250, titled "A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers." This Phase 1 study enrolled 96 participants and was a controlled, randomized trial, though it was not double-blind.

Is Serum containing Avonex the same as Avonex?

Serum containing Avonex is a formulation of Avonex that includes serum, while Avonex is typically a serum-free formulation. The drug is being studied to determine if the serum-containing version is bioequivalent to the standard serum-free Avonex for the treatment of Multiple Sclerosis.