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REGN17092

Phase 1

Undisclosed | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Mar 27, 2025

REGN17092 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

REGN17092 clinical trials

REGN17092 · 1 trial · 1 indication

Phase 1 1
NCT05923424A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy AdultsHealthy Volunteers
COMPLETED40 Analytics
PHASE1COMPLETED
A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of all treatment emergent adverse events (TEAEs)
Through approximately day 365
Severity of all TEAEs
Through approximately day 365
Occurrence of all treatment emergent serious adverse events (TE-SAEs)
Through approximately day 365
Severity of all TE-SAEs
Through approximately day 365

Secondary Endpoints

Concentrations of REGN17092 in serum over time
Through approximately day 365
Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time
Through approximately day 365
Titer of ADAs to REGN17092 over time
Through approximately day 365
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
REGN17092DRUGSingle 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 a 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 REGN17092

What is REGN17092?

REGN17092 is an investigational small molecule drug developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers rather than in patients with a specific disease. Regeneron has not disclosed the intended therapeutic indication for REGN17092.

Who makes REGN17092?

REGN17092 is made by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron is the developer responsible for the compound and for the Phase 1 study conducted in healthy volunteers.

What phase is REGN17092 in?

REGN17092 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was a randomized, double-blind, controlled trial that enrolled 40 healthy adult volunteers in Belgium.

What clinical trials is REGN17092 in?

REGN17092 has been evaluated in one clinical trial, NCT05923424, titled "A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults." The Phase 1 study enrolled 40 participants in Belgium, was randomized, double-blind, and controlled, and has been completed.

Is REGN17092 FDA approved?

REGN17092 is not approved. It is an investigational drug that has completed a single Phase 1 trial in healthy volunteers, which is the earliest stage of clinical testing. No regulatory approval has been granted for REGN17092.

What was studied in the REGN17092 Phase 1 trial?

The Phase 1 trial NCT05923424 evaluated different doses of REGN17092 for safety in healthy adults. It enrolled 40 participants aged 18 years and older in Belgium, used a randomized, double-blind, controlled design, and has been completed.