First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Other
Enrollment
118actual
Sites
2
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-22 | actual | When the study began enrolling |
| Primary completion | 2025-04-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-23 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants Study
Interventions
- Drug: KT-621
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFIncidence of adverse events
measured 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
measured 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
measured 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
measured 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)
measured 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)
measured 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)
measured 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)
measured 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)
measured From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
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