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KT-579

Phase 1

Undisclosed | Small molecule | Other |Kymera Therapeutics, Inc.|Trials Updated: Feb 27, 2026

KT-579 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2026

KT-579 target and mechanism

Molecular targetIRF5
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

KT-579 clinical trials

KT-579 · 1 trial · 1 indication

Phase 1 1
NCT07412288First-in-human Study of Orally Administered KT-579 in Healthy Adult ParticipantsHealthy Participants
RECRUITING96 Analytics
PHASE1RECRUITING
First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Incidence of serious adverse events
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Secondary Endpoints

Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data
Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Time to maximum concentration (Tmax): observed time to achieve maximum concentrations derived from plasma concentration data
Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Area under the curve (AUC0-last): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to the last observed timepoint
Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
KT-579ACTIVE_COMPARATOREach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579.
PlaceboPLACEBO_COMPARATOREach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

Interventions

NameTypeDescription
KT-579DRUGOral drug
PlaceboDRUGOral drug
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening. * Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compli...

Countries:United States
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Frequently asked questions about KT-579

What is KT-579?

KT-579 is an investigational oral small molecule being developed by Kymera Therapeutics, Inc. It is in Phase 1 clinical development and is currently being studied in healthy adult participants. KT-579 is designed to target IRF5, a protein involved in immune signaling. No approved indication has been established for KT-579.

What does KT-579 target?

KT-579 targets IRF5, also known as interferon regulatory factor 5. IRF5 is a transcription factor involved in immune and inflammatory signaling pathways. By targeting IRF5, KT-579 is designed to modulate this pathway. The drug is an orally administered small molecule.

Who makes KT-579?

KT-579 is being developed by Kymera Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol KYMR. Kymera Therapeutics is a biopharmaceutical company focused on targeted protein degradation. The company is the sponsor of the ongoing clinical trial for KT-579.

What phase is KT-579 in?

KT-579 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is a first-in-human study evaluating orally administered KT-579 in healthy adult participants.

What clinical trials is KT-579 in?

KT-579 is being evaluated in one active clinical trial, NCT07412288, titled "First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants." The trial is currently recruiting and is expected to enroll 96 participants. It is a randomized, double-blind, placebo-controlled Phase 1 study conducted in the United States.