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SYNB1020

Phase 1

Healthy Volunteer | Small molecule | Other |Synlogic, Inc.|Last Updated: May 12, 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_CONTROLLED
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03179878Safety and Tolerability of SYNB1020-CP-001PHASE1 COMPLETED 52Jun 16, 2017Apr 11, 2018May 12, 20211 United States
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events, Laboratory Assessments and ECGs to measure Safety and Tolerability of SYNB1020
3 months from study entry

Will be measured by assessing nature and frequency of AEs, Laboratory Assessments, and ECGs

Secondary Endpoints
GI tolerability measured using the Gastrointestinal Symptom Rating Scale (GSRS)
1 month of study entry
SYNB1020 kinetics measured by qPCR fecal assays
3 months from study entry
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SYNB1020EXPERIMENTALSYNB1020
PlaceboPLACEBO_COMPARATOR100 mL masking solution
Interventions
NameTypeDescription
PlaceboDRUGPlacebo
SYNB1020DRUGInvestigational Product
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Age 18 to 64 years * Healthy volunteer Males and Females; Females must be of non childbearing potential * Able and willing to complete informed consent process * Available for and agree to all study procedures * Screening Labs within normal range Key Exclusion Criteria: ...

Countries:United States
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