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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
118
Celerion
Phoenix, Arizona, United States
Celerion
Lincoln, Nebraska, United States
Incidence of adverse events
Time frame: 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
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes
Time frame: 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
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)
Time frame: 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
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
Time frame: 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)
Time frame: 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)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Time frame: 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)
Time frame: 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)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1, Day 7, and Day 14 (MAD)
Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis
Time frame: Day 1 (SAD) and Day 14 (MAD)
Fraction excreted: Fraction of drug excreted unchanged in urine
Time frame: Day 14 (MAD)