HealthyPhase 1NCT06703710
To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
A Phase 1 study testing JW2286 in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JW2286
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2025to Jan 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean or Caucasian volunteers
Who cannot join
- Individuals with a clinically significant disease or history
- Individuals with a history of a gastrointestinal disorder or surgery
- In the case of all female individuals with childbearing potential, except for those who are surgically sterile
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
Jaegu Kang, +82-2072-1666, rkdworn489@snu.ac.kr
SeungHwan Lee
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and PK Characteristics, and to Explore Food Effect and Ethnic Difference of JW2286 in Healthy Volunteers
This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.
- Conditions
- Healthy
- Being tested
- JW2286, Placebo of JW2286
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JW2286Drug
a single administration of JW2286 per dose
Placebo of JW2286Drug
a single administration of Placebo of JW2286 per dose
| Study group | Role | What they receive |
|---|---|---|
| Test group (JW2286) | Experimental | Ethnicity: Korean or Caucasian Receives: Drug: JW2286 |
| Placebo group (Placebo of JW2286) | Placebo comparator | Ethnicity: Korean or Caucasian Receives: Drug: Placebo of JW2286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
Pharmacokinetic Characteristics Evaluation
Measured: 0 to 168 hours
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
Pharmacokinetic Characteristics Evaluation
Measured: 0 to 168 hours
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
Pharmacokinetic Characteristics Evaluation
Measured: 0 to 168 hours
Time of Maximum Concentration (Tmax) of JW2286
Pharmacokinetic Characteristics Evaluation
Measured: 0 to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start6 Jan 2025
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703710
- Sponsor's protocol ID
- JW23104
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2024
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and PK Characteristics, and to Explore Food Effect and Ethnic Difference of JW2286 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06703710
- Acronym / sponsor ID
- JW23104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 25 Nov 2024 (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 trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (JW2286) | Experimental | Drug: JW2286Ethnicity: Korean or Caucasian |
| Placebo group (Placebo of JW2286) | Placebo comparator | Drug: Placebo of JW2286Ethnicity: Korean or Caucasian |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Korean or Caucasian volunteers
Key exclusion criteria (3 listed)
- Individuals with a clinically significant disease or history
- Individuals with a history of a gastrointestinal disorder or surgery
- In the case of all female individuals with childbearing potential, except for those who are surgically sterile
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 |
|---|---|---|
| JW2286a single administration of JW2286 per dose | Drug | Test group (JW2286) |
| Placebo of JW2286a single administration of Placebo of JW2286 per dose | Drug | Placebo group (Placebo of JW2286) |
Primary outcome
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286
Time frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) of JW2286
Time frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
The maximum or peak concentration between zero and dosing interval (Cmax) of JW2286
Time frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
Time of Maximum Concentration (Tmax) of JW2286
Time frame: 0 to 168 hours
Pharmacokinetic Characteristics Evaluation
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 13 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
SeungHwan 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 JW2286 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 1 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 13 Jan 2025. 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. Some participants in this study may receive a placebo. 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 Hyeona Kim (+82-840-6791, hyeona.kim@jwhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma drug concentration-time curve from 0 to last (AUClast) of JW2286 (time frame: 0 to 168 hours). The study lists 4 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 13 Jan 2025.