A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
86
Seoul National University Hospital
Seoul, South Korea
RECRUITINGNumber of participants with Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Number of participants with Adverse Events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in vital signs
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
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