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REGN3470-3471-3479

Phase 1

Undisclosed | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Feb 5, 2018

REGN3470-3471-3479 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

REGN3470-3471-3479 clinical trials

REGN3470-3471-3479 · 1 trial · 1 indication

Phase 1 1
NCT02777151Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult VolunteersHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
From baseline up to day 169

Secondary Endpoints

Concentration of REGN3479 in serum over time
From baseline up to day 169
Concentration of REGN3471 in serum over time
From baseline up to day 169
Concentration of REGN3470 in serum over time
From baseline up to day 169
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALREGN3470-3471-3479 dosing level 1 or placebo
Cohort 2EXPERIMENTALREGN3470-3471-3479 dosing level 2 or placebo
Cohort 3EXPERIMENTALREGN3470-3471-3479 dosing level 3 or placebo
Cohort 4EXPERIMENTALREGN3470-3471-3479 dosing level 4 or placebo

Interventions

NameTypeDescription
REGN3470-3471-3479DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy man or woman between the ages of 18 and 60 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent 5. Able to understand and complete study-related que...

Countries:United States
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Frequently asked questions about REGN3470-3471-3479

What is REGN3470-3471-3479?

REGN3470-3471-3479 is an investigational small molecule therapeutic being developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to assess its safety, tolerability, and pharmacokinetics. The specific disease indications for which it is being developed have not been disclosed.

Who is developing REGN3470-3471-3479?

REGN3470-3471-3479 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol REGN. Regeneron is the sponsor of the clinical program for this asset.

What phase is REGN3470-3471-3479 in?

REGN3470-3471-3479 is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy adult volunteers. There are currently no active trials of REGN3470-3471-3479 listed.

What clinical trials is REGN3470-3471-3479 in?

REGN3470-3471-3479 has been evaluated in one completed Phase 1 trial, NCT02777151, titled "Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers." The trial enrolled 24 participants in the United States and was randomized, double-blind, and controlled.

Is REGN3470-3471-3479 FDA approved?

No, REGN3470-3471-3479 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. It remains in clinical development and has not received marketing authorization for any indication.