NCT07514780 To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers
| NCT ID | NCT07514780 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | JW Pharmaceutical |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2026-04-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Seung Hwan Lee
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT07514780 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07514780 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07514780 currently recruiting?
Yes, NCT07514780 is actively recruiting participants. Contact the research team at soyoun1628@jwhealthcare.com for enrollment information.
Where is the NCT07514780 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07514780 clinical trial?
NCT07514780 is sponsored by JW Pharmaceutical. The principal investigator is Seung Hwan Lee at Seoul National University Hospital. The trial plans to enroll 104 participants.