Safety and how the body handles JW0061 when applied to the skin of healthy adults
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
Run by JW Pharmaceutical · NCT07514780 · Data updated 2026-11-12
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 |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | JW Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07514780 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: soyoun1628@jwhealthcare.com
- Phone: +82-2-840-6797
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.