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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
JW0061 SAD
DrugSingle ascending doses
JW0061 MAD
DrugMultiple ascending doses
Placebo
DrugMatching placebo for JW0061
Treatment groups
104 Participants
are divided into 4 treatment groupsGroup A: Part 1: SADExperimental treatment 2 interventions
Group B: Part 1: MADExperimental treatment 2 interventions
Group C: Part 2: SADExperimental treatment 1 intervention
Group D: Part 2: MADExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability will be assessed by monitoring the frequency and severity of Adverse Events (AEs). Adverse events are categorized into Pre-Treatment Adverse Events (PTAEs) and Treatment-Emergent Adverse Events (TEAEs).
Time frame
SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 282
Skin Irritation Assessment - Subjective
Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness).
Time frame
SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 283
Skin Irritation Assessment - Objective
Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness/scaling, folliculitis, edema, and papules).
Time frame
SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 284
Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.
Time frame
SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28Sponsors and contacts
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Source ClinicalTrials.gov