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NVP-VAK694

Phase 1

Allergic Rhinitis | Small molecule | Other |Novartis AG|Last Updated: Sep 27, 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_CONTROLLED
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00620230Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic SubjectsPHASE1 COMPLETED 46Oct 1, 2007Apr 1, 2008Sep 27, 20101 United States
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Study Endpoints
Primary Endpoints
Routine safety observations and pharmacokinetic measurements
throughout the study
Secondary Endpoints
Routine safety observations and pharmacokinetic measurements
throughout the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NVP-VAK694DRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * History of allergic rhinitis (Part 2 only) Exclusion Criteria: * Very low or high body weight * Heavy or recent smoker * Exposure to human monoclonal antibodies Other protocol-defined inclusion/exclusion criteria may apply.

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials