To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers

Primary outcomes

1. Treatment-Emergent Adverse Events (TEAEs)

   Time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28

   Safety and tolerability will be assessed by monitoring the frequency and severity of Adverse Events (AEs). Adverse events are categorized into Pre-Treatment Adverse Events (PTAEs) and Treatment-Emergent Adverse Events (TEAEs).

2. Skin Irritation Assessment - Subjective

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness).

3. Skin Irritation Assessment - Objective

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness/scaling, folliculitis, edema, and papules).

4. Systolic Blood Pressure

   Time frame: 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 will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.

5. Diastolic Blood Pressure

   Time frame: 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 will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.

6. Pulse Rate

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Pulse rate will be measured in beats per minute (bpm). Any clinically significant abnormal findings will be collected as adverse events.

7. Body Temperature

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Body temperature will be measured in degrees Celsius (°C). Any clinically significant abnormal findings will be collected as adverse events.

8. 12-lead ECG

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Safety is assessed through 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcB. Clinically significant findings, such as rhythm abnormalities, are collected as adverse events.

9. Shift from Baseline in Laboratory Test Results

   Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28

   Laboratory test results are classified as normal, clinically non-significant abnormal, or clinically significant abnormal, and presented in a shift table from baseline. Measurements are performed using standard clinical laboratory methods.

10. Physical Examination (Normal/Abnormal)

    Time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28

    Physical examination findings categorized as normal or abnormal based on a comprehensive assessment including medical history review, interview, inspection, palpation, percussion, and auscultation, as assessed by the investigator.