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KT-579

Phase 1

Healthy Participants | Small molecule | Other |Kymera Therapeutics, Inc.|Last Updated: Feb 27, 2026

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

Clinical trial landscape

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 used for?

KT-579 is an investigational small molecule being developed by Kymera Therapeutics for use in healthy participants. It is currently in Phase 1 clinical development, with an ongoing first-in-human study evaluating its safety, tolerability, and pharmacokinetics after oral administration.

What does KT-579 target?

KT-579 targets IRF5, a transcription factor involved in immune regulation. By modulating IRF5 activity, the drug is being studied for its potential effects in healthy participants, though its specific therapeutic application has not been disclosed.

Who makes KT-579?

KT-579 is being developed by Kymera Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol KYMR. The company is conducting a Phase 1 clinical trial of KT-579 in healthy adult participants.

What phase is KT-579 in?

KT-579 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a first-in-human trial to assess its safety and tolerability in healthy volunteers.

What clinical trials is KT-579 in?

KT-579 is being evaluated in a Phase 1 clinical trial with the identifier NCT07412288, titled "First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants." This randomized, double-blind, placebo-controlled study is recruiting 96 participants in the United States.

Is KT-579 the same as any other drug?

No alternative names for KT-579 have been disclosed. It is a distinct investigational small molecule developed by Kymera Therapeutics, and no other drug names have been associated with it in available clinical trial information.