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Recruiting Phase 1 NCT07514780

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: JW Pharmaceutical

trial.available_in: БГ
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.
Who can participate
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.
Interventions
JW0061 SAD
DRUG
JW0061 MAD
DRUG
Placebo
DRUG
Locations 1
South Korea (1)
Seoul National University Hospital Clinical Trial Center
Seoul , Seoul
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
19 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
13.04.2026
Completion date
30.04.2027
Registry ID
NCT07514780
Source
clinicaltrials.gov
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