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AST-008

Phase 1

Healthy Volunteer Study | Small molecule | Other |Exicure, Inc.|Last Updated: Sep 25, 2018

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03086278A Study of AST-008 in Healthy SubjectsPHASE1 COMPLETED 16Oct 20, 2017Aug 16, 2018Sep 25, 20181 United Kingdom
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Study Endpoints
Primary Endpoints
Serious related adverse events
Up to 1 month after the last dose of AST-008

To evaluate SAEs after a single subcutaneous dose of AST-008

Adverse events
Up to 1 month after the last dose of AST-008

To evaluate adverse events after a single subcutaneous dose of AST-008

Secondary Endpoints
Dose finding
Up to 1 month after the last dose of AST-008
Maximum plasma concentration assessment
Up to 1 month after the last dose of AST-008
AUC assessment
Up to 1 month after the last dose of AST-008
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Study Design & Arms
MaskingNONE
ModelSEQUENTIAL
PurposeSCREENING
Treatment Arms
ArmTypeDescription
Single Ascending DoseEXPERIMENTAL -
Interventions
NameTypeDescription
AST-008DRUGAST-008 is a toll-like receptor 9 agonist.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Main Inclusion Criteria: 1. Healthy male or female subjects aged ≥18 and ≤40 years of age at the time of first dosing. 2. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive. 3. Satisfactory medical assessment with no clinically significant or relevant abnormalities as dete...

Countries:United Kingdom
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