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REGN10933+REGN10987

Phase 1

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jan 26, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment974

FDA Designations

No designations recorded

Clinical trial landscape

REGN10933+REGN10987 · 1 trial · 2 indications

Phase 1 1
NCT04519437Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19Healthy
COMPLETED974 Analytics
PHASE1COMPLETED
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19
Healthy
NCT04519437974
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Study Endpoints

Primary Endpoints

Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Within 4 days postdose at Baseline
Concentrations of REGN10933 in serum over time
Up to 52 weeks
Concentrations of REGN10987 in serum over time
Up to 52 weeks

Secondary Endpoints

Proportion of participants with treatment-emergent adverse events (TEAEs)
Up to 52 weeks
Severity of TEAEs
Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10933
Up to 52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGN10933+REGN10987EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
REGN10933+REGN10987DRUGAdministered subcutaneous (SC) every 4 weeks (Q4W)
PlaceboDRUGAdministered subcutaneous (SC) every 4 weeks (Q4W)
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersYes
Study Sites7

Key Inclusion Criteria: 1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study 2. Stable medication for co-morbid condition(s) for at least 6 months prior ...

Countries:United States
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Frequently asked questions about REGN10933+REGN10987

What is REGN10933+REGN10987 used for?

REGN10933+REGN10987 is an investigational combination of two monoclonal antibodies being studied for the prevention and treatment of COVID-19. It has been evaluated in clinical trials for hospitalized adult patients with COVID-19, for prevention of SARS-CoV-2 infection in healthy adults and adolescents who are household contacts of infected individuals, and in healthy adult volunteers.

What does REGN10933+REGN10987 target?

REGN10933+REGN10987 targets the spike (S) protein of SARS-CoV-2, the virus that causes COVID-19. The combination consists of two anti-spike monoclonal antibodies designed to bind to the spike protein and potentially neutralize the virus.

Who makes REGN10933+REGN10987?

REGN10933+REGN10987 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company has conducted multiple clinical trials to evaluate the safety and efficacy of this antibody combination for COVID-19.

What phase is REGN10933+REGN10987 in?

REGN10933+REGN10987 has completed Phase 1, Phase 2, and Phase 3 clinical trials. The trials include a Phase 3 study for prevention of SARS-CoV-2 infection in healthy adults and adolescents, and a Phase 1/2/3 study for hospitalized adult patients with COVID-19. All trials are completed.

What clinical trials is REGN10933+REGN10987 in?

REGN10933+REGN10987 has been studied in four completed clinical trials. NCT04426695 evaluated its efficacy in hospitalized adults with COVID-19. NCT04452318 assessed its efficacy for prevention of SARS-CoV-2 infection in healthy household contacts. NCT04519437 studied safety, tolerability, and pharmacokinetics in healthy volunteers. NCT04666441 evaluated virologic efficacy in adult outpatients with SARS-CoV-2 infection.

Is REGN10933+REGN10987 the same as REGN10933 and REGN10987?

REGN10933+REGN10987 is a combination of two monoclonal antibodies, REGN10933 and REGN10987, administered together. The combination is sometimes referred to by the individual component names, but in clinical trials it is studied as a fixed combination product.