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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KT-579 | Active Comparator | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579. |
|
| Placebo | Placebo Comparator | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KT-579 | Drug | Oral drug |
| |
| Placebo |
| Measure | Description | 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) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in IRF5 protein levels in whole blood and peripheral blood mononuclear cells (SAD) | Day 1 | |
| Change from baseline in IRF5 protein levels in whole blood, peripheral blood mononuclear cells, and skin (MAD) | Day 1 to Day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kymera Medical Director | Contact | 857-285-5300 | clinicaltrials@kymeratx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Recruiting | Lincoln | Nebraska | 68502 | United States |
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The Sponsor is also masked to treatment allocation.
| Drug |
Oral drug |
|
| 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) |