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SD-101

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Dynavax Technologies Corporation|Last Updated: Apr 16, 2019

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00823862Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) InfectionPHASE1 COMPLETED 34Oct 1, 2008Feb 1, 2010Apr 16, 20195 Poland
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Study Endpoints
Primary Endpoints
Adverse event timing, duration, and severity.
Between doses and up to 3 months after last dose
Secondary Endpoints
Biomarker analysis of blood sample
pre and 24 hour post dose
Viral load in blood sample
each visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active (SD-101)EXPERIMENTALSD-101 in cohorts of escalating doses
Interventions
NameTypeDescription
SD-101DRUGIntramuscular (IM)
ribavirinDRUGoral, 2 times per day, for 2 months
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Signed, written, informed consent * Male or female subjects, 18 to 55 years of age. * Subject must have chronic infection HCV, genotype 1. * Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL * No prior treatment for HCV. * Must be negative for hepatitis B (HBV) an...

Countries:Poland
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