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

NCT06673667 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KT621-HV-101
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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

Keywords

Phase 1; STAT6; STAT6 degrader; targeted protein degrader

Outcome Measures

Primary Outcomes (9)

• Incidence of adverse events

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology

  Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry

  Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation

  Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

• Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius)

  From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Secondary Outcomes (7)

• 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)

Other Outcomes (2)

• Change from baseline in STAT6 protein levels in whole blood and peripheral blood mononuclear cells (SAD)

  Day 1

• Change from baseline in STAT6 protein levels in whole blood, peripheral blood mononuclear cells, and skin (MAD)

  Day 1 to Day 14

Study Arms (2)

KT-621

ACTIVE COMPARATOR

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

Drug: KT-621

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KT-621 DRUG

Oral drug

KT-621

Placebo DRUG

Oral drug

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (2)

Celerion

Phoenix, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor is also masked to treatment allocation.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 5, 2024
• Study Start: October 22, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)