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Modified Release rhTSH

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: Mar 18, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00137891Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating HormonePHASE1 COMPLETED 46 — — Jun 1, 2005Aug 1, 2005Mar 18, 20151 United States
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Study Endpoints
Primary Endpoints
To assess and compare the pharmacokinetics (PK) of a single intramuscular (IM) administration of 0.1 mg of Thyrogen versus a single IM administration of 0.1 mg modified release formulation of rhTSH in healthy subjects
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Study Design & Arms
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Modified Release rhTSHDRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Committed to follow the protocol requirements as evidenced by providing written informed consent prior to any study-related procedures being performed * Males or females, in good general health, between the ages of 18 and 40, inclusive. Females of childbearing potential must b...

Countries:United States
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