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MDX1106-02

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 23, 2010

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00703469A Study of MDX-1106 to Treat Patients With Hepatitis C InfectionPHASE1 COMPLETED 54Oct 1, 2008Oct 1, 2009Apr 23, 20107 United States
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Study Endpoints
Primary Endpoints
safety, tolerability, and immunogenicity
One year
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MDX1106-02DRUGSingle dose
PlaceboDRUGPlacebo single dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Infection with hepatitis C genotype 1 or mixed hepatitis C genotype; * Asymptomatic or nearly asymptomatic from hepatitis C; * Previous therapy with interferon and ribavirin or peginterferon and ribavirin without an SVR or relapsed following an SVR;or Interferon naive subjects...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials