COMPLETED

First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants

Conditions

Healthy Participants Study Phase 1 STAT6 STAT6 degrader targeted protein degrader

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.

Official Title

A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-621 in Healthy Adult Participants

Quick Facts

Study Start:2024-10-22

Study Completion:2025-04-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06673667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Participants aged 19 to 55 years (inclusive) at the time of consent, 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 30.0 kg/m² (inclusive) at Screening. * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. * Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Male participants (and their partners of childbearing potential) and female participants must agree to the contraception requirements as specified in the clinical protocol. * Female participants may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration. * Female participants must have a negative result for pregnancy test at Screening and on admission to the CRU.	* 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 (eg, 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 5 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 admission to the CRU (eg, 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-621 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-621/placebo administration.

Inclusion Criteria

Exclusion Criteria

* Participants aged 19 to 55 years (inclusive) at the time of consent, 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 30.0 kg/m² (inclusive) at Screening.
* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Male participants (and their partners of childbearing potential) and female participants must agree to the contraception requirements as specified in the clinical protocol.
* Female participants may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
* Female participants must have a negative result for pregnancy test at Screening and on admission to the CRU.

* 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 (eg, 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 5 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 admission to the CRU (eg, 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-621 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-621/placebo administration.

Contacts and Locations

Study Locations (Sites)

Celerion

Phoenix, Arizona, 85283

United States

Celerion

Lincoln, Nebraska, 68502

United States

Collaborators and Investigators

Sponsor: Kymera Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-22

Study Completion Date2025-04-23

Study Record Updates

Study Start Date2024-10-22

Study Completion Date2025-04-23

Terms related to this study

Keywords Provided by Researchers

Phase 1
STAT6
STAT6 degrader
targeted protein degrader

Additional Relevant MeSH Terms

Healthy Participants Study