HealthyPhase 1NCT07514780
To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers
A Phase 1 study testing JW0061 SAD and JW0061 MAD in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JW0061 SAD and JW0061 MAD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Apr 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital Clinical Trial Center
Seoul, Seoul, 110-744
SeungHwan Lee
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial to Evaluate the Safety, Pharmacokinetic and Pharmadynamics of JW0061 Following Topical Application in Korean and Caucasians Healthy Adults
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- JW0061 SAD, JW0061 MAD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JW0061 SADDrug
Also called JW0061
Single ascending doses
JW0061 MADDrug
Also called JW0061
Multiple ascending doses
PlaceboDrug
Matching placebo for JW0061
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD | Experimental | Up to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults. Receives: Drug: JW0061 SAD; Drug: Placebo |
| Part 1: MAD | Experimental | Up to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults. Receives: Drug: JW0061 MAD; Drug: Placebo |
| Part 2: SAD | Experimental | Up to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults. Receives: Drug: JW0061 SAD |
| Part 2: MAD | Experimental | Up to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults. Receives: Drug: JW0061 MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28
Skin Irritation Assessment - Subjective
Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness).
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Skin Irritation Assessment - Objective
Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness/scaling, folliculitis, edema, and papules).
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
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.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Pulse Rate
Pulse rate will be measured in beats per minute (bpm). Any clinically significant abnormal findings will be collected as adverse events.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Body Temperature
Body temperature will be measured in degrees Celsius (°C). Any clinically significant abnormal findings will be collected as adverse events.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
12-lead ECG
Safety is assessed through 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcB. Clinically significant findings, such as rhythm abnormalities, are collected as adverse events.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Shift from Baseline in Laboratory Test Results
Laboratory test results are classified as normal, clinically non-significant abnormal, or clinically significant abnormal, and presented in a shift table from baseline. Measurements are performed using standard clinical laboratory methods.
Measured: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Physical Examination (Normal/Abnormal)
Physical examination findings categorized as normal or abnormal based on a comprehensive assessment including medical history review, interview, inspection, palpation, percussion, and auscultation, as assessed by the investigator.
Measured: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung Hwan Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514780
- Sponsor's protocol ID
- JW25104
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial to Evaluate the Safety, Pharmacokinetic and Pharmadynamics of JW0061 Following Topical Application in Korean and Caucasians Healthy Adults
- ClinicalTrials.gov ID
- NCT07514780
- Acronym / sponsor ID
- JW25104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD | Experimental | Drug: JW0061 SAD, Drug: PlaceboUp to five cohorts (S1-S5) (n = 40). Conducted in healthy Korean adults. |
| Part 1: MAD | Experimental | Drug: JW0061 MAD, Drug: PlaceboUp to five cohorts (M1-M5) (n = 40). Conducted in healthy Korean adults. |
| Part 2: SAD | Experimental | Drug: JW0061 SADUp to two cohorts (S6-S7) (n = 12). Conducted in healthy Caucasian adults. |
| Part 2: MAD | Experimental | Drug: JW0061 MADUp to two cohorts (M6-M7) (n = 12). Conducted in healthy Caucasian adults. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JW0061 SADAlso: JW0061Single ascending doses | Drug | Part 1: SAD, Part 2: SAD |
| JW0061 MADAlso: JW0061Multiple ascending doses | Drug | Part 1: MAD, Part 2: MAD |
| PlaceboMatching placebo for JW0061 | Drug | Part 1: MAD, Part 1: SAD |
Primary outcome
Treatment-Emergent Adverse Events (TEAEs)
Time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28
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).
Skin Irritation Assessment - Subjective
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Evaluation of skin safety using participant-reported subjective irritation (itching, prickling, burning, stinging, and tightness).
Skin Irritation Assessment - Objective
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Evaluation of skin safety using investigator-observed objective irritation (erythema, dryness/scaling, folliculitis, edema, and papules).
Systolic Blood Pressure
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.
Diastolic Blood Pressure
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Any clinically significant abnormal findings will be collected as adverse events.
Pulse Rate
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Pulse rate will be measured in beats per minute (bpm). Any clinically significant abnormal findings will be collected as adverse events.
Body Temperature
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Body temperature will be measured in degrees Celsius (°C). Any clinically significant abnormal findings will be collected as adverse events.
12-lead ECG
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Safety is assessed through 12-lead ECG parameters, including heart rate, PR interval, QRS duration, QT interval, and QTcB. Clinically significant findings, such as rhythm abnormalities, are collected as adverse events.
Shift from Baseline in Laboratory Test Results
Time frame: SAD: From baseline (Day 1 pre-dose) up to Day 8, MAD: From baseline (Day 1 pre-dose) up to Day 28
Laboratory test results are classified as normal, clinically non-significant abnormal, or clinically significant abnormal, and presented in a shift table from baseline. Measurements are performed using standard clinical laboratory methods.
Physical Examination (Normal/Abnormal)
Time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28
Physical examination findings categorized as normal or abnormal based on a comprehensive assessment including medical history review, interview, inspection, palpation, percussion, and auscultation, as assessed by the investigator.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seung Hwan Lee principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JW0061 SAD and JW0061 MAD in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soyeon Jeong (+82-2-840-6797, soyoun1628@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events (TEAEs) (time frame: SAD: From Screening(Day -28) up to Day 8, MAD: From Screening(Day -28) up to Day 28). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.