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Formulation buffers

Phase 1

Healthy | Unknown | Other |Sanofi|Last Updated: Jan 31, 2013

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
Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01401764Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy SubjectsPHASE1 COMPLETED 30 — — May 1, 2011Jun 1, 2011Jan 31, 20131 Belgium
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Study Endpoints
Primary Endpoints
Relative perception of pain of platform II versus PASS using a likert scale
0 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
0 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
0 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
0 minute after injections
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Study Design & Arms
AllocationNA
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Platform II, PASS, ARG 100OTHER -
Interventions
NameTypeDescription
Formulation buffersOTHERPlatform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory. * Body mass index of 17.5 to 30.5 kg/m2; and a to...

Countries:Belgium
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