Recent Updates
Recently added Catalysts

ILV-095

Phase 1

Healthy Subjects | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 6, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00822484Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male SubjectsPHASE1 COMPLETED 48 — — Feb 1, 2009Sep 1, 2009May 6, 20111 Japan
NCT00822835Study Evaluating Single Doses of ILV-095 in Healthy SubjectsPHASE1 COMPLETED 48 — — Jan 1, 2009Aug 1, 2009Sep 18, 20091 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
3 weeks per group
Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
3 weeks per group
Secondary Endpoints
Pharmacokinetic parameters
3 weeks per group
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ILV-095ACTIVE_COMPARATOR6 SC single dose injections
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
ILV-095BIOLOGICAL -
PlaceboOTHER -
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration. * Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body...

Countries:JapanUnited States
Unlock Eligibility Criteria