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SPY003-207

Phase 2

Undisclosed | Small molecule | Other |Spyre Therapeutics, Inc.|Trials Updated: Mar 20, 2026

SPY003-207 development status

Highest phase Phase 2 (NCT07652294)
Phase scored for SYREPhase 1
Registered trials 3 across 1 sponsor since Mar 2025

SPY003-207 target and mechanism

Molecular targetIL-23p19
ModalitySmall molecule

Also known as SPY003

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

SPY003-207 clinical trials

SPY003-207 · 1 trial · 1 indication

Phase 1 1
NCT06873724A Study of SPY003-207 in Healthy VolunteersHealthy
ACTIVE NOT_RECRUITING59 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of SPY003-207 in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment emergent adverse events
Up to 63 weeks

Incidence, severity, and causal relationship of TEAEs

Secondary Endpoints

Cmax
Up to 63 weeks
Tmax
Up to 63 weeks
t1/2
Up to 63 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAD Cohorts 1-6 Experimental ArmEXPERIMENTALParticipants will receive a single dose of SPY003-207 in a dose escalation format
SAD Cohorts 1-6 Placebo ArmPLACEBO_COMPARATORParticipants will receive a single dose of placebo
SAD Cohort 7, Experimental ArmEXPERIMENTALParticipants of Chinese descent will receive a single dose of SPY003-207-101
SAD Cohort 7, Placebo ArmPLACEBO_COMPARATORParticipants of Chinese descent will receive a single dose of placebo
MAD Cohorts 1 Experimental ArmEXPERIMENTALParticipants will receive two doses of SPY003-207-101 in a dose escalation format
MAD Cohorts 1 Placebo ArmPLACEBO_COMPARATORParticipants will receive two doses of placebo

Interventions

NameTypeDescription
SPY003-207DRUGExperimental
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy men and women * Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits Exclusion Criteria: * Participation in more...

Countries:United StatesCanada
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Frequently asked questions about SPY003-207

What is SPY003-207?

SPY003-207 is an investigational small molecule being developed by Spyre Therapeutics, Inc. It is in Phase 1 clinical development and is being studied in healthy adult volunteers. Spyre Therapeutics trades on the Nasdaq under the ticker SYRE.

What does SPY003-207 target?

SPY003-207 targets IL-23p19. IL-23p19 is a subunit of the interleukin-23 cytokine, and targeting it is a mechanism used to modulate IL-23 signaling. SPY003-207 is a small molecule directed at this target.

Who makes SPY003-207?

Spyre Therapeutics, Inc. is developing SPY003-207. The company is publicly traded on the Nasdaq under the ticker symbol SYRE. Spyre Therapeutics is the sponsor of the clinical program for this asset.

What phase is SPY003-207 in?

SPY003-207 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program currently has one active Phase 1 trial, with no completed trials reported.

What clinical trials is SPY003-207 in?

SPY003-207 is being studied in the Phase 1 trial NCT06873724, titled A Study of SPY003-207 in Healthy Volunteers. The trial is active but not recruiting, is randomized, double blind, and placebo controlled, and plans to enroll 59 participants in the United States and Canada.

Who can enroll in the SPY003-207 trial?

The Phase 1 trial NCT06873724 for SPY003-207 enrolls healthy adult volunteers. Participants must be 18 years of age or older, and both sexes are eligible. The study is being conducted at sites in the United States and Canada.