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ST266

Phase 1

Cytokine Release Syndrome | Monoclonal antibody | Other |IQVIA Holdings, Inc.|Last Updated: Jun 15, 2022

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04720378Safety and Tolerability Study of IV ST266 in COVID-19 SubjectsPHASE1 COMPLETED 12May 30, 2021May 3, 2022Jun 15, 20223 United States
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Study Endpoints
Primary Endpoints
Incidence and Severity of Treatment-Emergent Adverse Events
3 months

Determine the incidence and severity of treatment-emergent adverse events related to the IV administration of ST266 based on findings from physical examinations, laboratory evaluations, vital signs, and ECG measurements.

Secondary Endpoints
Pulse Oximetry
14 days
Fever
14 days
Clinical Status on Ordinal Scale
14 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL0.1 ml/kg IV ST266 once a day for 5 days
Cohort 2EXPERIMENTAL0.25 ml/kg IV ST266 once a day for 5 days
Cohort 3EXPERIMENTAL0.5 ml/kg IV ST266 once a day for 5 days
Cohort 4EXPERIMENTAL1.0 ml/kg IV ST266 once a day for 5 days
Interventions
NameTypeDescription
ST266BIOLOGICAL1X ST266
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Males and non-pregnant/non-breastfeeding females age 18-70 years of age. 2. Laboratory confirmed SARS-CoV-2 infection determined by PCR or other commercial/public health assay (test results must be obtained within 7-days of the Screening Visit). 3. BMI between 18 and 39 inclu...

Countries:United States
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