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SAGE-217 high dose

Phase 1

Healthy | Small molecule | Other |Biogen Inc.|Last Updated: Nov 29, 2023

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03284931A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia ModelPHASE1 COMPLETED 45 — — Sep 14, 2017Dec 18, 2017Nov 29, 20231 United States
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Study Endpoints
Primary Endpoints
Sleep efficiency, as determined by polysomnography (PSG)
16 days
Secondary Endpoints
Safety and tolerability, as assessed by adverse events
36 days
Safety and tolerability, as assessed by vital signs
29 days
Safety and tolerability, as assessed by clinical laboratory data
29 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAGE-217 high doseEXPERIMENTALSAGE-217
SAGE-217 low doseEXPERIMENTALSAGE-217
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
SAGE-217 high doseDRUGhigh dose
PlaceboDRUGplacebo
SAGE-217 low doseDRUGlow dose
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits * Subject is a healthy, ambulatory volunteer * Subject meets sleep Qualification criteria Exclusion Criteria: * Subject has a medical history ...

Countries:United States
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