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REGN14284

Phase 1

Undisclosed | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Jul 27, 2023

REGN14284 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2022

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

REGN14284 clinical trials

REGN14284 · 1 trial · 1 indication

Phase 1 1
NCT05505448A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult ParticipantsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence and severity of all treatment emergent adverse events (TEAEs)
Through approximately day 169
Occurrence and severity of all severe adverse events (SAEs)
Through approximately day 169

Secondary Endpoints

Concentrations of REGN14284 in serum over time
Through approximately day 169
Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time
Through approximately day 90
Titer of ADAs to REGN14284 over time
Through approximately day 90
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 Mid IV DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 2 Mid SC DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 3 High IV DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 4 High SC DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 5 Higher IV DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 6 Highest IV DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 7 Low IV DoseEXPERIMENTALRandomized 3:1 for single ascending dose
Cohort 8 Low SC DoseEXPERIMENTALRandomized 3:1 for single ascending dose

Interventions

NameTypeDescription
REGN14284DRUGSingle ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
Matching PlaceboDRUGSingle ascending IV or SC administration per the protocol
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Has SARS-CoV-2-negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol. 2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening 3....

Countries:Belgium
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Frequently asked questions about REGN14284

What is REGN14284?

REGN14284 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN). It is being studied as a COVID-19 therapeutic. The drug is in Phase 1 clinical development and has been evaluated in a single completed trial in healthy adult participants.

Who makes REGN14284?

REGN14284 is made by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the developer responsible for the clinical program evaluating this small molecule as a COVID-19 therapeutic.

What phase is REGN14284 in?

REGN14284 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this drug.

What clinical trials is REGN14284 in?

REGN14284 has been studied in one clinical trial: NCT05505448, a Phase 1 trial titled "A Trial to Learn if a COVID-19 Therapeutic is Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants." The trial was completed, enrolled 48 healthy adult participants in Belgium, and was randomized, double-blind, and controlled.

Is REGN14284 FDA approved?

No, REGN14284 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development. The only listed trial for REGN14284 has been completed, and no active trials are currently reported.