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BAF 312

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Nov 29, 2007

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 Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00422175Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312PHASE1 COMPLETED 63Oct 1, 2006Nov 1, 2007Nov 29, 20071 United States
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Study Endpoints
Primary Endpoints
safety, tolerability, and pharmacokinetic profile
Maximum Tolerated Dose
Secondary Endpoints
Lymphocyte counts and lymphocyte recovery period
Cardiac rate and rhythm
Pulmonary function
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
BAF 312DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects, 18 to 55 years of age included, and in good health * Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 1 years) * Female subjects ...

Countries:United States
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