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

NCT ID: NCT06673667

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2025-04-23

Brief Summary

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.

Conditions

Healthy Participants Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

KT-621

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621.

Group Type: ACTIVE_COMPARATOR

KT-621

Intervention Type: DRUG

Oral drug

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral drug

Interventions

KT-621

Oral drug

Intervention Type: DRUG

Placebo

Oral drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

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 (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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kymera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion

Phoenix, Arizona, United States

Celerion

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

KT621-HV-101

Identifier Type: -

Identifier Source: org_study_id