HealthyPhase 1NCT06378684

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

A Phase 1 study testing Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3), Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) and Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers 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?: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3), Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) and Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: 10 Sep 2023to 13 Jan 2024
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy volunteers

Who cannot join

Subjects does not meet the Inclusion Criteria

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Clinical Trial Center, Severance Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Read the detailed description

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Conditions: Healthy
Being tested: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3), Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3), Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3), Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3), Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)Drug
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Study groups in NCT06378684
Study group	Role	What they receive
Group 1	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)
Group 2	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)
Group 3	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)
Group 4	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)
Group 5	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)
Group 6	Other	Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration Receives: Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax,ss
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Measured: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
AUCτ,ss
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Measured: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202313 Jan 2024

First posted22 Apr 2024
Study start10 Sep 2023
Primary completion23 Dec 2023
Study completion13 Jan 2024

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: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06378684
Sponsor's protocol ID: JW22105
Status last verified: Apr 2024
First submitted: 29 Mar 2024
Last updated: 22 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults
ClinicalTrials.gov ID: NCT06378684
Acronym / sponsor ID: JW22105
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: JW PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 10 Sep 2023 (actual)
Primary completion: 23 Dec 2023 (actual)
Study completion: 13 Jan 2024 (actual)
First posted: 22 Apr 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.

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Detailed description

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Group 1	Other	Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 2	Other	Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 3	Other	Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 4	Other	Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 5	Other	Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
Group 6	Other	Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy volunteers

Key exclusion criteria (1 listed)

Subjects does not meet the Inclusion Criteria

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
Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 1
Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 2
Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 3
Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 4
Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 5
Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration	Drug	Group 6

Primary outcome

Cmax,ss
Time frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
AUCτ,ss
Time frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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. This study is not recruiting at the moment.

MinSoo Kim principal investigator

Severance Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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: finished, as of the sponsor's last update on 22 Apr 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax,ss (time frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378684.

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 22 Apr 2024.