Healthy Participants
Conditions
Keywords
Phase 1, IRF5, IRF5 degrader, targeted protein degrader
Brief summary
This is a first-in-human study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-579 in healthy male and female adult participants.
Interventions
DRUGKT-579
Oral drug
DRUGPlacebo
Oral drug
Sponsors
Kymera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The Sponsor is also masked to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants 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 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 (e.g. 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 2 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 on admission to the CRU (e.g. 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-579 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-579/placebo administration. * Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of study drug. * 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 breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration. * Female participants with a positive or undetermined pregnancy test at Screening and on admission to the CRU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD) |
| Incidence of serious adverse events | From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis | Day 1 (SAD) and Day 14 (MAD) |
| Fraction excreted: Fraction of drug excreted unchanged in urine | Day 14 (MAD) |
Countries
United States
Contacts
CONTACTKymera Medical Director
Outcome results
None listed