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REGN846

Phase 1

Healthy | Monoclonal antibody | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

REGN846 · 1 trial · 1 indication

Phase 1 1
NCT01209793Safety and Tolerability Study of REGN846 (SAR302352) in Healthy VolunteersHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Healthy
NCT0120979340
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Study Endpoints

Primary Endpoints

Incidence and severity of adverse events
Baseline through end of study

Secondary Endpoints

PK profile
Baseline through end of study
Immunogenicity
Visits 2, 8, 10 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose 1EXPERIMENTAL(3:1, active: placebo)
Dose 2EXPERIMENTAL(3:1, active: placebo)
Dose 3EXPERIMENTAL(3:1, active: placebo)
Dose 4EXPERIMENTAL(3:1, active: placebo)
Dose 5EXPERIMENTAL(3:1, active: placebo)

Interventions

NameTypeDescription
REGN846BIOLOGICAL5 IV cohorts (Dose 1, 2, 3, 4, 5)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile * Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive * Normal vital signs after resting in a sitting position for 5 minutes: * Normal standard 12-lead ECG * Willin...

Countries:Australia
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Frequently asked questions about REGN846

What is REGN846?

REGN846 is an investigational monoclonal antibody being developed by Regeneron Pharmaceuticals, Inc. (REGN). It is currently in Phase 1 clinical development. The drug is being studied for use in healthy volunteers, and it has completed one clinical trial.

What is REGN846 used for?

REGN846 is being studied for use in healthy volunteers. It is an investigational monoclonal antibody in Phase 1 clinical development. The completed trial focused on safety and tolerability in healthy individuals, and the drug is not yet approved for any medical condition.

Who makes REGN846?

REGN846 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker REGN. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development.

What phase is REGN846 in?

REGN846 is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied in healthy volunteers. The drug has completed one Phase 1 trial, and it is not yet approved by regulatory authorities.

What clinical trials is REGN846 in?

REGN846 has been studied in one clinical trial, NCT01209793, titled 'Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers.' This Phase 1 trial was completed and enrolled 40 participants in Australia. The study was randomized, double-blind, and controlled.