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REGN3470-3471-3479

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 5, 2018

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

Clinical trial landscape

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
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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 used for?

REGN3470-3471-3479 is an investigational drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics in healthy adult volunteers. The drug is not approved for any indication and remains in clinical testing.

Who makes REGN3470-3471-3479?

REGN3470-3471-3479 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. Regeneron is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers. The company's stock is traded under the ticker symbol REGN.

What phase is REGN3470-3471-3479 in?

REGN3470-3471-3479 is in Phase 1 clinical development. A Phase 1 study has been completed, which involved 24 healthy adult volunteers. The drug is investigational and has not been approved by regulatory authorities. It is still in the early stages of clinical testing.

What clinical trials is REGN3470-3471-3479 in?

REGN3470-3471-3479 has one completed clinical trial, identified as NCT02777151. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of the drug in healthy adult volunteers. The trial was conducted in the United States and enrolled 24 participants.

Is REGN3470-3471-3479 FDA approved?

REGN3470-3471-3479 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. The drug is still in clinical development and has not been approved for any medical use by the FDA or other regulatory agencies.