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

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.

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.

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.