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KT-579

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07412288First-in-human Study of Orally Administered KT-579 in Healthy Adult ParticipantsPHASE1 RECRUITING 96 — — Feb 23, 2026Dec 1, 2026Feb 27, 20261 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07412288primaryCompletionDate: changed
LOWMay 24, 2026NCT07412288studyFirstPostDate: changed