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ST266

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

ST266 · 1 trial · 1 indication

Phase 1 1
NCT04720378Safety and Tolerability Study of IV ST266 in COVID-19 SubjectsCytokine Release Syndrome
COMPLETED12 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
Cytokine Release SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about ST266

What is ST266 used for?

ST266 is an investigational monoclonal antibody being studied for the treatment of Cytokine Release Syndrome. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and tolerability in patients with this condition.

Who is developing ST266?

ST266 is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. The drug is currently in Phase 1 clinical development for Cytokine Release Syndrome, an immunology-related condition.

What phase is ST266 in?

ST266 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of Cytokine Release Syndrome.

What clinical trials is ST266 in?

ST266 has one completed clinical trial registered under NCT04720378, titled "Safety and Tolerability Study of IV ST266 in COVID-19 Subjects." This Phase 1 trial enrolled 12 participants in the United States and studied the drug's use in Cytokine Release Syndrome. The trial was controlled but not randomized or double-blind.

Is ST266 a monoclonal antibody?

Yes, ST266 is a monoclonal antibody. It is being investigated as a potential treatment for Cytokine Release Syndrome. The drug is currently in Phase 1 clinical development and is not yet approved for any use.