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ILV-095

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

ILV-095 · 2 trials · 1 indication

Phase 1 2
NCT00822484Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male SubjectsHealthy Subjects
COMPLETED48 Analytics
NCT00822835Study Evaluating Single Doses of ILV-095 in Healthy SubjectsHealthy Subjects
COMPLETED48 Analytics
PHASE1COMPLETED
Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects
Healthy Subjects
NCT0082248448
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PHASE1COMPLETED
Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Healthy Subjects
NCT0082283548
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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
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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 -
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Eligibility Criteria

Age Range20 Years to 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
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Frequently asked questions about ILV-095

What is ILV-095?

ILV-095 is an investigational monoclonal antibody being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy subjects in two completed trials, one in Japan and one in the United States.

What is ILV-095 used for?

ILV-095 is being studied for use in healthy subjects. It is an investigational monoclonal antibody in Phase 1 clinical development. The completed trials evaluated single doses of ILV-095 in healthy volunteers, but no specific disease indication has been reported.

Who makes ILV-095?

ILV-095 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development.

What phase is ILV-095 in?

ILV-095 is in Phase 1 clinical development. It is an investigational monoclonal antibody being developed by Pfizer, Inc. Two Phase 1 trials studying the drug in healthy subjects have been completed, but the drug is not yet approved and remains in clinical development.

What clinical trials is ILV-095 in?

ILV-095 has been studied in two completed Phase 1 clinical trials. NCT00822484 evaluated single doses in healthy Japanese male subjects in Japan, and NCT00822835 evaluated single doses in healthy subjects in the United States. Both trials were placebo-controlled and double-blind.

Is ILV-095 the same as any other drug?

No alternative names for ILV-095 have been reported. The drug is an investigational monoclonal antibody being developed by Pfizer, Inc. It is currently in Phase 1 clinical development and has been studied in healthy subjects in two completed trials.