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

A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-579 in Healthy Adult Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: KT-579

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kymera Medical Director; Phone Number: 857-285-5300; Email: clinicaltrials@kymeratx.com

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Recruiting
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.	Drug: Placebo; Oral drug
Active Comparator: KT-579; Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579.	Drug: KT-579; Oral drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis	Day 1 (SAD) and Day 14 (MAD)
Fraction excreted: Fraction of drug excreted unchanged in urine	Day 14 (MAD)

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kymera Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; targeted protein degrader; IRF5; IRF5 degrader
• Other Study ID Numbers: KT579-HV-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No