Healthy
Conditions
Brief summary
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.
Detailed description
The study is divided into two parts: * Part 1 (Korean Healthy Adults): Consists of 5 cohorts each for Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) stages. * Part 2 (Caucasian Healthy Adults): Consists of 2 cohorts each for SAD and MAD stages to evaluate the drug in a different ethnic group.
Interventions
DRUGJW0061 SAD
Single ascending doses
DRUGJW0061 MAD
Multiple ascending doses
DRUGPlacebo
Matching placebo for JW0061
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight between 50.0 kg and 90.0 kg, and BMI between 18.5 and 29.9 kg/m². * Determined to be healthy and eligible by the investigator based on medical history, physical examination, and clinical laboratory tests. * Capable of providing written informed consent and willing to comply with all study requirements and restrictions.
Exclusion criteria
* Presence of clinically significant scalp conditions that may interfere with safety assessments. * History of malignancy within 5 years prior to screening. * History of hypersensitivity or allergy to the study drug or its components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events (TEAEs) | 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). |
| Skin Irritation Assessment - Subjective | 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). |
| Skin Irritation Assessment - Objective | 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). |
| Systolic Blood Pressure | 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. |
| Diastolic Blood Pressure | 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. |
| Pulse Rate | 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. |
| Body Temperature | 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. |
| 12-lead ECG | 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. |
| Shift from Baseline in Laboratory Test Results | 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. |
| Physical Examination (Normal/Abnormal) | 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. |
Countries
South Korea
Contacts
CONTACTSoyeon Jeong
CONTACTInyoung Park
PRINCIPAL_INVESTIGATORSeung Hwan Lee
Seoul National University Hospital
Outcome results
None listed