Recruiting

Phase 1

KT-621A Study to Evaluate Different Oral Formulations of KT-621

Sponsor:

Kymera Therapeutics, Inc.

Code:

NCT07823205

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

KT-621

Study Details

Brief summary:

This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants.

Conditions

Healthy Participants

Study ID

NCT07823205

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

Participants with a weight of at least 50 kilograms (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 (for example, surgery of the GI tract that could interfere with the PK of the study medication). Note: prior appendectomy or cholecystectomy is not exclusionary.
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 have acute GI symptoms at the time of Screening or admission to the CRU (for example, nausea, vomiting, diarrhea, heartburn).
Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening or on admission to the CRU.
Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives, or time determined by local requirements (whichever is longer) prior to admission to the CRU.
Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of KT-621.
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 breastfeeding, or plan to become pregnant during study participation or within 30 days of the last dose of KT-621.
Female participants with a positive or undetermined pregnancy result at the Screening visit or at admission to the CRU.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Part A: KT-621 Test Formulation #1

Participants will receive KT-621 in different oral formulations in a one-way crossover design.

experimental: Part B: KT-621 Test Formulation #2

Participants will receive KT-621 in different oral formulations in a one-way crossover design.

Interventions

KT-621

KT-621 Reference Oral Formulation

KT-621

KT-621 Test Oral Formulation #1

KT-621

KT-621 Test Oral Formulation #2

Primary outcome measure

Maximum Plasma Concentration (Cmax) of KT-621 [ Time Frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B) ]
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621 [ Time Frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B) ]
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621 [ Time Frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B) ]

Central Contacts and Locations

Central contacts

Kymera Medical Director

857-285-5300 clinicaltrials@kymeratx.com

Locations

Celerion

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Kymera Therapeutics, Inc.

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

STAT6
STAT6 degrader
targeted protein degrader

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Kymera Therapeutics, Inc. on 2026-09-16.