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Recruiting NCT07514780

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JW0061 SAD, JW0061 MAD, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug JW0061 SAD
    Single ascending doses
  • Drug JW0061 MAD
    Multiple ascending doses
  • Drug Placebo
    Matching placebo for JW0061

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Physical Examination (Normal/Abnormal) [Time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital Clinical Trial Center — Seoul

Identifiers

NCT: NCT07514780 · JW25104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗