To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorJW Pharmaceutical
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JW0061 SAD
- JW0061 MAD
- Placebo
Treatment groups
104 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov