First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants

NCT07412288 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: KT579-HV-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Phase 1; IRF5; IRF5 degrader; targeted protein degrader

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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)

• Area under the curve (AUC0-infinity): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to infinite time

  Day 1 (SAD)

• Area under the curve (AUC0-tau): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to end of the dosing interval

  Day 1, Day 7, and Day 14 (MAD)

Other Outcomes (2)

• Change from baseline in IRF5 protein levels in whole blood and peripheral blood mononuclear cells (SAD)

  Day 1

• Change from baseline in IRF5 protein levels in whole blood, peripheral blood mononuclear cells, and skin (MAD)

  Day 1 to Day 14

Study Arms (2)

KT-579

ACTIVE COMPARATOR

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

Drug: KT-579

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KT-579 DRUG

Oral drug

KT-579

Placebo DRUG

Oral drug

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

RECRUITING

Central Study Contacts

Kymera Medical Director

CONTACT

857-285-5300; clinicaltrials@kymeratx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor is also masked to treatment allocation.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)