To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Healthy
Спонсор: JW Pharmaceutical
Налично на:
БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Интервенции
JW0061 SAD
DRUG
JW0061 MAD
DRUG
Placebo
DRUG
Места на провеждане
1
Южна Корея (1)
Seoul National University Hospital Clinical Trial Center