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REGN846

Phase 1

Undisclosed | Monoclonal antibody | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Jun 1, 2012

REGN846 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2010

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

REGN846 clinical trials

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
HealthyUnlock trial analytics

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 developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. REGN846 is not approved for any indication and remains in early clinical development.

Who makes REGN846?

REGN846 is developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. The company sponsored the Phase 1 study of REGN846 conducted in Australia.

What phase is REGN846 in?

REGN846 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not advanced beyond early-stage clinical testing, and REGN846 is not approved for any use.

What clinical trials has REGN846 been studied in?

REGN846 has been evaluated in one Phase 1 trial, NCT01209793, titled a safety and tolerability study in healthy volunteers. The trial enrolled 40 participants, was randomized, double-blind, and controlled, and was conducted in Australia. It is listed as completed.

Is REGN846 the same as SAR302352?

Yes, SAR302352 is an alternative designation used for REGN846. The Phase 1 trial NCT01209793 refers to the drug as REGN846 (SAR302352), so both names identify the same monoclonal antibody candidate.

What was the design of the REGN846 Phase 1 trial?

The REGN846 Phase 1 trial, NCT01209793, was a randomized, double-blind, controlled study of safety and tolerability in healthy volunteers. It enrolled 40 participants aged 18 years and older of all sexes in Australia. The study is complete.