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REGN728

Phase 1

Undisclosed | Monoclonal antibody | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Nov 12, 2012

REGN728 development status

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

REGN728 target and mechanism

Molecular targetangiopoietin-2 (ANG2)
Target classProtein
ModalityMonoclonal antibody

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

REGN728 clinical trials

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 developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. Regeneron has not publicly disclosed the specific disease indications being pursued for this asset, so its intended therapeutic use remains undisclosed.

What does REGN728 target?

REGN728 targets angiopoietin-2, also known as ANG2, a protein. Angiopoietin-2 is a signaling protein involved in vascular biology, and REGN728 is a monoclonal antibody designed to bind it. The target class is a protein, and the antibody modality is intended to modulate ANG2 activity.

Who makes REGN728?

REGN728 is developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program for this monoclonal antibody. The company has not disclosed the specific disease indications it intends to pursue with REGN728.

What phase is REGN728 in?

REGN728 is in Phase 1 development. It is an investigational monoclonal antibody and has not been approved by the FDA. The only recorded trial, NCT01197391, is a completed Phase 1 study, and no active trials are currently listed for this asset.

What clinical trials is REGN728 in?

REGN728 has been studied in one clinical trial, NCT01197391, titled "Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers." This completed Phase 1 trial enrolled 48 healthy adult volunteers in the United States and used a randomized, double-blind, controlled design.