This clinical study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation clinical trial to evaluate the safety, pharmacokinetic and pharmacodynamics of JW0061 following topical application in Korean and Caucasians healthy adults.
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Treatment-Emergent Adverse Events (TEAEs)
Timeframe: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28
Skin Irritation Assessment - Subjective
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Skin Irritation Assessment - Objective
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Systolic Blood Pressure
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Diastolic Blood Pressure
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Pulse Rate
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Body Temperature
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
12-lead ECG
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Shift from Baseline in Laboratory Test Results
Timeframe: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Physical Examination (Normal/Abnormal)
Timeframe: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28