Recruiting
Phase 1

KT-579

Sponsor:

Kymera Therapeutics, Inc.

Code:

NCT07412288

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

KT-579

Placebo

Study Details

Brief summary:

This is a first-in-human study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-579 in healthy male and female adult participants.

Conditions

Healthy Participants

Study ID

NCT07412288

Start date

Feb 23, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 compliance with requirements and restrictions listed in the ICF and in this protocol.
  • Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.
  • Participants who have a clinically relevant surgical history (e.g. surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
  • Participants with a history of alcohol or substance abuse within the previous 2 years.
  • Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
  • Participants who test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
  • Participants who have acute GI symptoms at the time of Screening or on admission to the CRU (e.g. nausea, vomiting, diarrhea, heartburn).
  • Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening and on admission to the CRU.
  • Participants who have previously received KT-579 in another cohort in this study.
  • Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives (whichever is longer) of KT-579/placebo administration.
  • Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of study drug.
  • Male participants (and their partners of childbearing potential) and female participants who do not agree to the contraception requirements as specified in the clinical protocol.
  • Female participants who are pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
  • Female participants with a positive or undetermined pregnancy test at Screening and on admission to the CRU.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: KT-579

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579.

placebo comparator: Placebo

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

Interventions

KT-579

Oral drug

Placebo

Oral drug

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kymera Medical Director

857-285-5300clinicaltrials@kymeratx.com

Locations

Celerion

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Kymera Therapeutics, Inc.

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Phase 1
  • IRF5
  • IRF5 degrader
  • targeted protein degrader

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kymera Therapeutics, Inc. on 2026-02-27.