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ILV-095

Phase 1

Undisclosed | Monoclonal antibody | Other |Pfizer, Inc.|Trials Updated: May 6, 2011

ILV-095 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jan 2009

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

ILV-095 clinical trials

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 SubjectsUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Healthy SubjectsUnlock trial analytics

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 developed by Pfizer, Inc. (ticker PFE). It is in Phase 1 clinical development, and its specific therapeutic indication has not been disclosed. The program has completed two Phase 1 trials in healthy volunteers, one in the United States and one in Japan.

Who makes ILV-095?

ILV-095 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored both Phase 1 clinical trials of the monoclonal antibody, one conducted in the United States and one in Japan, each enrolling 48 healthy subjects.

What phase is ILV-095 in?

ILV-095 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 96 healthy subjects across the United States and Japan.

What clinical trials is ILV-095 in?

ILV-095 has been studied in two completed Phase 1 trials. NCT00822835 evaluated single doses in healthy subjects in the United States, and NCT00822484 evaluated single doses in healthy Japanese male subjects in Japan. Each trial enrolled 48 participants, and both were randomized, double-blind, and placebo-controlled.

Is ILV-095 FDA approved?

ILV-095 is not approved. It is an investigational monoclonal antibody still in Phase 1 clinical development, with two completed Phase 1 trials in healthy volunteers. Pfizer, Inc. (ticker PFE) is the developer.