This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.
Healthy young and elderly adult volunteers who meet the criteria, will be treated single and multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be conducted with single ascending dose. After the single ascending dose study, independent external experts will review blinded data and multiple ascending dose study will be conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Capsule
Seoul National University Hospital
Seoul, South Korea
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 9
Area Under the Curve (AUC)
Time frame: Day 1 to Day 9
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 to Day 9
Apparent clearance (CL/F)
Time frame: Day 1 to Day 9
Apparent volume of distribution (Vz/F)
Time frame: Day 1 to Day 9
Incidence of Adverse Events (AEs)
Time frame: Up to 48 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 48 days
Incidence of clinically significant changes in vital signs
Time frame: Up to 18 days
Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory results
Time frame: Up to 18 days
Incidence of clinically significant changes in physical examination
Time frame: Up to 18 days
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