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LY3200327

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 12, 2016

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02595736A Study of LY3200327 in Healthy ParticipantsPHASE1 COMPLETED 52 — — Nov 1, 2015Aug 1, 2016Sep 12, 20161 United States
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to study completion (approximately 12 weeks)
Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327
Pre-dose up to 84 days post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327
Pre-dose up to 84 days post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Placebo (SC)PLACEBO_COMPARATORSingle subcutaneous (SC) dose of placebo
LY3200327 (SC)EXPERIMENTALSingle escalating subcutaneous (SC) dose of LY3200327
LY3200327 (IV)EXPERIMENTALSingle intravenous (IV) dose of LY3200327
Placebo (IV)PLACEBO_COMPARATORSingle intravenous (IV) dose of placebo
Interventions
NameTypeDescription
Placebo (SC)DRUGAdministered SC
LY3200327 (SC)DRUGAdministered SC
LY3200327 (IV)DRUGAdministered IV
Placebo (IV)DRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * At the time of initial screening, in general good health * First-generation healthy Japanese (age 20 to 65 years) will be included Exclusion Criteria: * Pregnancy or breastfeeding during the study * Chronic infection * Treatment with prohibited medications

Countries:United States
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