First human test of oral KT-579 in healthy adults
A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-579 in Healthy Adult Participants
This trial will test how safe and tolerable single and multiple oral doses of KT-579 are and how the body absorbs and responds to the drug in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Kymera Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT07412288 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, randomized interventional trial of oral KT-579 with placebo control in healthy male and female adults. The study uses single and multiple ascending dose cohorts to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Participants must meet weight and BMI requirements and have no clinically relevant medical or surgical history that could confound results. Study procedures require on-site dosing and scheduled laboratory and clinical assessments.
Who should consider this trial
Good fit: Healthy adults (male ≥50 kg or female ≥40 kg) with BMI 18.0–32.0 kg/m² who can read and sign informed consent and comply with study visits and procedures are ideal candidates.
Not a fit: People with significant medical conditions, relevant surgical histories (for example GI surgeries affecting drug absorption), or other exclusionary health issues would not be expected to benefit or be eligible.
Why it matters
Potential benefit: If successful, KT-579 could enable a new oral class of IRF5-targeted degraders that may provide targeted therapies for immune-mediated diseases.
How similar studies have performed: Targeted protein degraders are an emerging therapeutic approach with early clinical programs for other targets, but first-in-human data specifically for IRF5 degraders are not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lincoln, Nebraska
- Celerion — Lincoln, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Kymera Medical Director
- Email: clinicaltrials@kymeratx.com
- Phone: 857-285-5300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.