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REGN14284

Phase 1

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 27, 2023

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

Clinical trial landscape

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
Healthy
NCT0550544848
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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 being developed by Regeneron Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug is being studied for use in healthy adult participants, and it is not yet approved for any indication.

What is REGN14284 used for?

REGN14284 is being studied as a potential COVID-19 therapeutic. It is currently in Phase 1 clinical trials to evaluate its safety, tolerability, and how it works in the body of healthy adult participants. The drug is not yet approved for any use.

Who makes REGN14284?

REGN14284 is being developed by Regeneron Pharmaceuticals, Inc., which is publicly traded under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule drug.

What phase is REGN14284 in?

REGN14284 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.

What clinical trials is REGN14284 in?

REGN14284 has one completed Phase 1 clinical trial, registered as NCT05505448. This trial was a randomized, double-blind, controlled study that enrolled 48 healthy adult participants in Belgium to evaluate the safety, tolerability, and pharmacokinetics of the drug.

Is REGN14284 FDA approved?

REGN14284 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was designed to assess safety and tolerability in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory review.