A Study to Evaluate Different Oral Formulations of KT-621

NCT07823205 | Recruiting Phase 1 FDA Drug

• 1 other identifier: KT621-HV-105
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Keywords

STAT6; STAT6 degrader; targeted protein degrader

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of KT-621

  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

  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

  Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)

Secondary Outcomes (2)

• Incidence of adverse events

  From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)

• Incidence of serious adverse events

  From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)

Study Arms (2)

Part A: KT-621 Test Formulation #1

EXPERIMENTAL

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

Drug: KT-621

Part B: KT-621 Test Formulation #2

EXPERIMENTAL

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

Drug: KT-621

Interventions

KT-621 DRUG

KT-621 Reference Oral Formulation

Part A: KT-621 Test Formulation #1; Part B: KT-621 Test Formulation #2

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 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.

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 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.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts A and B use an open-label, one-way crossover design in which participants receive KT-621 interventions in a fixed sequence across multiple treatment periods.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)