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
Abstract
This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.
Conditions: Healthy Participants Study.
Primary outcome: Incidence of adverse events; Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology; Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry; Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation; Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds); Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute); Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg); Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute); Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius).
Enrollment: 118 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 118 participants or records.
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