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TT301

Phase 1

Traumatic Brain Injury | Small molecule | Other |Opko Health Inc.|Last Updated: Jun 6, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01357421Effects of TT301 on Cytokine Levels Post Endotoxin ChallengePHASE1 COMPLETED 18May 1, 2011Jun 1, 2011Jun 6, 20131 United States
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Study Endpoints
Primary Endpoints
Cytokine levels post LPS challenge
Measured up to 12h post-LPS
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TT301EXPERIMENTALInvestigational drug TT301
PlaceboPLACEBO_COMPARATORNormal saline
Interventions
NameTypeDescription
TT301DRUGSingle iv dose of TT301
PlaceboDRUGSingle iv dose of 0.9% sodium chloride for injection USP
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male * 18 to 40 years, inclusive * 55 - 95 kg, inclusive Exclusion Criteria: * Evidence of any clinically significant disease * History of cancer * History of syncope or severe vasovagal events * Antibiotic treatment within 60 days of Day 1 * Surgical procedure within 60 day...

Countries:United States
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