Testing KT-621 in healthy adults
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
This study is testing a new oral drug called KT-621 in healthy adults to see how it works in the body and if it's safe compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Sponsor | Kymera Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT06673667 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacokinetics, and pharmacodynamics of KT-621, an orally administered drug, in healthy adult participants. It involves administering single and multiple doses of KT-621 and comparing the effects to a placebo. The study aims to gather data on how the drug behaves in the body and its potential effects on health. Participants will be closely monitored throughout the study to ensure their safety and compliance with the protocol.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 19 to 55 years who meet specific weight and BMI criteria.
Not a fit: Patients who are pregnant, lactating, or have certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of KT-621, paving the way for its use in treating conditions related to STAT6.
How similar studies have performed: While this is a first-in-human study, similar approaches in targeted protein degradation have shown promise in preclinical and early-phase studies.
Eligibility criteria
Show full inclusion / exclusion 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.
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.