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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.
The study is divided into two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: SAD | Experimental | Up to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults. |
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| Part 1: MAD | Experimental | Up to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults. |
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| Part 2: SAD | Experimental | Up to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults. |
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| Part 2: MAD | Experimental | Up to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JW0061 SAD | Drug | Single ascending doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events (TEAEs) | 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). | SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28 |
| Skin Irritation Assessment - Subjective | Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness). | 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 | Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness/scaling, folliculitis, edema, and papules). | 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 | Systolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events. | 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 | Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events. | SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28 |
| Pulse Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soyeon Jeong | Contact | +82-2-840-6797 | soyoun1628@jwhealthcare.com | |
| Inyoung Park | Contact | +82-2-840-6887 | inyoung.park@jwhealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Recruiting | Seoul | Seoul | 110-744 | South Korea |
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial
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| JW0061 MAD | Drug | Multiple ascending doses |
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| Placebo | Drug | Matching placebo for JW0061 |
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Pulse rate will be measured in beats per minute (bpm). Any clinically significant abnormal findings will be collected as adverse events.
| SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28 |
| Body Temperature | Body temperature will be measured in degrees Celsius (°C). Any clinically significant abnormal findings will be collected as adverse events. | 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 | 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. | 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 | 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. | 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) | 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. | SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28 |