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TD-6450

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Theravance Biopharma, Inc.|Last Updated: Jan 19, 2021

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment158
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02116543TD-6450 MAD Study in HCV Infected SubjectsPHASE1 COMPLETED 47May 1, 2014Nov 1, 2014Jan 19, 20211 United States
NCT02022306TD-6450 SAD and MAD in Healthy SubjectsPHASE1 COMPLETED 111Feb 1, 2014Sep 1, 2014Jan 14, 20211 United States
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Study Endpoints
Primary Endpoints
Adverse events
28 Days

Number, type, severity, and association of treatment emergent adverse events.

Secondary Endpoints
Cmax
28 Days
Tmax
28 Days
AUC0-t
28 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TD-6450EXPERIMENTALTD-6450 capsules
PlaceboPLACEBO_COMPARATORPlacebo capsules
SAD TD-6450PLACEBO_COMPARATORSingle ascending dose (Part A)
MAD TD-6450PLACEBO_COMPARATORMultiple ascending dose (Part B)
Food effect of TD-6450ACTIVE_COMPARATORFood effect will be assessed in Part A (SAD) of this study.
Interventions
NameTypeDescription
TD-6450DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is HCV antibody positive * Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals. * Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials