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REGN17092

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 27, 2025

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

Clinical trial landscape

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
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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 being developed by Regeneron Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to assess its safety, and it is not yet approved for any medical use.

What is REGN17092 used for?

REGN17092 is being studied for use in healthy volunteers. The completed Phase 1 trial aimed to evaluate the safety of different doses of the drug in healthy adults. It is an investigational agent and has not been approved for any specific disease or condition.

Who makes REGN17092?

REGN17092 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron is conducting clinical research on this investigational small molecule.

What phase is REGN17092 in?

REGN17092 is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on evaluating the safety of different doses in healthy adults. The drug remains investigational and has not received regulatory approval.

What clinical trials is REGN17092 in?

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

Is REGN17092 FDA approved?

REGN17092 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. The drug is still in clinical development and has not been authorized for any medical use.