Safety and how the body handles JW0061 when applied to the skin of healthy adults

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 trial will test how safe JW0061 is and how it is absorbed and acts when applied to the skin of healthy Korean and Caucasian adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: JW Pharmaceutical (Industry-sponsored)
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07514780 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, dose-escalation phase 1 trial using topical JW0061 in healthy volunteers. Part 1 enrolls Korean adults with five cohorts each for single ascending dose (SAD) and multiple ascending dose (MAD) stages, while Part 2 enrolls Caucasian adults with two cohorts each for SAD and MAD. The study collects safety, pharmacokinetic, and pharmacodynamic data to characterize local and systemic effects after topical application. Placebo-controlled dosing and stepwise escalation are used to identify tolerable dose ranges and early PK/PD signals.

Who should consider this trial

Good fit: Healthy Korean or Caucasian adults who weigh 50.0–90.0 kg, have a BMI of 18.5–29.9 kg/m², can give informed consent, and have no significant scalp disease or recent malignancy.

Not a fit: People with active scalp conditions, known allergy to the investigational product or its components, recent cancer within five years, or those outside the weight/BMI limits are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify safe topical dose levels and schedules that enable later patient trials of JW0061.

How similar studies have performed: Dose-escalation, randomized, placebo-controlled phase 1 studies of topical drugs commonly establish safety and PK/PD profiles, but JW0061 itself has not been previously tested in humans.

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.

Where this trial is running

Seoul, Seoul

• Seoul National University Hospital Clinical Trial Center — Seoul, Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: Seung Hwan Lee — Seoul National University Hospital
• Study coordinator: Soyeon Jeong

Conditions Healthy