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Набира участници Фаза 1 NCT07514780

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
Seoul , Seoul
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
19 Years
Максимална възраст
55 Years
Здрави доброволци
Не
Начална дата
13.04.2026
Крайна дата
30.04.2027
Регистрационен номер
NCT07514780
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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