RecruitingPhase 1NCT07514780

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

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


Sponsor

JW Pharmaceutical

Enrollment

104 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

DRUGJW0061 SAD

Single ascending doses

DRUGJW0061 MAD

Multiple ascending doses

DRUGPlacebo

Matching placebo for JW0061


Locations(1)

Seoul National University Hospital Clinical Trial Center

Seoul, Seoul, South Korea

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NCT07514780


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