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Interferon beta 1a

Phase 1

Multiple Sclerosis (MS) | Small molecule | Immunology |Biogen Inc.|Last Updated: May 27, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01863069Avonex®: Safety, Blood Levels and EffectsPHASE1 COMPLETED 77Jan 1, 2001Oct 1, 2001May 27, 20131 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameter
10 months

Serum concentrations of human interferon-beta

Pharmacodynamic parameter
10 months

Serum concentrations of neopterin and beta2-microglobulin

Number of adverse events
10 months

Adverse events throughout the study

Clinically relevant changes from baseline in safety assessments
10 months

Routine physical examination, ECG, safety tests of blood/urine, CXR, oximetry, full pulmonary function tests, spirometry, Dyspnea scale

Pharmacodynamic paramter
10 months

Cellular MxA protein as an exploratory analysis

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeBASIC_SCIENCE
Interventions
NameTypeDescription
Interferon beta 1aDRUG -
(IM) AVONEX®DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be between the ages of 18 and 45 years, inclusive. * Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline). * Must give written informed consent. Exclusion Criteria: * H...

Countries:United Kingdom
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