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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial to Evaluate the Safety, Pharmacokinetic and Pharmadynamics of JW0061 Following Topical Application in Korean and Caucasians Healthy Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: JW0061 SAD; Drug: Placebo; Drug: JW0061 MAD

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Soyeon Jeong; Phone Number: +82-2-840-6797; Email: soyoun1628@jwhealthcare.com
• Study Contact Backup: Name: Inyoung Park; Phone Number: +82-2-840-6887; Email: inyoung.park@jwhealthcare.com

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 110-744
      • Recruiting
      • Seoul National University Hospital Clinical Trial Center
      • Principal Investigator: SeungHwan Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: SAD; Up to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults.	Drug: JW0061 SAD; Single ascending doses; Other Names: JW0061; Drug: Placebo; Matching placebo for JW0061
Experimental: Part 1: MAD; Up to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults.	Drug: Placebo; Matching placebo for JW0061; Drug: JW0061 MAD; Multiple ascending doses; Other Names: JW0061
Experimental: Part 2: SAD; Up to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults.	Drug: JW0061 SAD; Single ascending doses; Other Names: JW0061
Experimental: Part 2: MAD; Up to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults.	Drug: JW0061 MAD; Multiple ascending doses; Other Names: JW0061

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: Seung Hwan Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JW25104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No