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REGN728

Phase 1

Healthy | Monoclonal antibody | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 12, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

REGN728 · 1 trial · 1 indication

Phase 1 1
NCT01197391Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy VolunteersHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint in the study is the percentage of subjects with treatment emergent adverse events, reported from the administration of study drug on day 1 to the completion of the study on day 106.
106 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALDose 1 versus placebo
Cohort 2EXPERIMENTALDose 2 versus placebo

Interventions

NameTypeDescription
REGN728BIOLOGICAL2 Subcutaneous Cohorts (dose 1, 2)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male or female 18 to 65 years of age. * Weight\> 50 kg and \<95 kg inclusive * For men of childbearing potential, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study. * Willing, committed, and able...

Countries:United States
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Frequently asked questions about REGN728

What is REGN728?

REGN728 is an investigational monoclonal antibody being developed by Regeneron Pharmaceuticals, Inc. (REGN). It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy volunteers to assess its safety and tolerability.

What is REGN728 used for?

REGN728 is being studied for use in healthy volunteers. The completed Phase 1 trial evaluated the safety and tolerability of ascending doses of REGN728 in healthy individuals. Its potential therapeutic applications have not been established, as it is still in early-stage clinical development.

Who makes REGN728?

REGN728 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. Regeneron is conducting clinical research on REGN728 as an investigational monoclonal antibody.

What phase is REGN728 in?

REGN728 is in Phase 1 clinical development. A Phase 1 trial, NCT01197391, has been completed. This trial was a randomized, double-blind, controlled ascending dose study in healthy volunteers. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is REGN728 in?

REGN728 has one completed clinical trial, NCT01197391, titled "Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers." This Phase 1 study enrolled 48 healthy participants in the United States and was randomized, double-blind, and controlled.