Overview
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.
Description
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.
Eligibility
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.
