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

NCT07514780 | Recruiting Phase 1

• 1 other identifier: JW25104
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (4)

Part 1: SAD

EXPERIMENTAL

Up to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults.

Drug: JW0061 SAD; Drug: Placebo

Part 1: MAD

EXPERIMENTAL

Up to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults.

Drug: JW0061 MAD; Drug: Placebo

Part 2: SAD

EXPERIMENTAL

Up to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults.

Drug: JW0061 SAD

Part 2: MAD

EXPERIMENTAL

Up to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults.

Drug: JW0061 MAD

Interventions

JW0061 SAD DRUG

Single ascending doses

Also known as: JW0061

Part 1: SAD; Part 2: SAD

JW0061 MAD DRUG

Multiple ascending doses

Also known as: JW0061

Part 1: MAD; Part 2: MAD

Placebo DRUG

Matching placebo for JW0061

Part 1: MAD; Part 1: SAD

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, Seoul, 110-744, South Korea

RECRUITING

Study Officials

• Seung Hwan Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soyeon Jeong

CONTACT

+82-2-840-6797; soyoun1628@jwhealthcare.com

Inyoung Park

CONTACT

+82-2-840-6887; inyoung.park@jwhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: April 7, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)