HealthyPhase 1NCT04018170
Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers
A Phase 1 study testing Study drug in people with Healthy, run by JW Pharmaceutical at 2 sites in South Korea.
Trial summary
This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult 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?
- Study drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Feb 2019to 15 Dec 2019
- 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
- Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study
Who cannot join
- Subjects judged by the investigators unsuitable for participating in the study based on any other reasons
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Severance Hospital
Seoul, 06725
Seoul National University Hospital
Seoul
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase I Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of JW1601
This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers
Read the detailed description
This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.
- Conditions
- Healthy
- Being tested
- Study drug, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study drugDrug
Also called JW1601
oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg
PlaceboDrug
oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets
| Study group | Role | What they receive |
|---|---|---|
| JW1601 | Experimental | tablet formulation Receives: Drug: Study drug |
| Placebo | Placebo comparator | tablet formulation identified with JW1601 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
Measured: From Day 1 through Post Study Visit (Day 8)
Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
Measured: From Day 1 through Post Study Visit (Day 14)
Secondary outcomes (10)
Cmax in plasma in single ascending dose administration
Maximum concentration of drug in plasma
Measured: Baseline(Day 1) through Day 4
Tmax in plasma in single ascending dose administration
Time to maximum plasma concentration
Measured: Baseline(Day 1) through Day 4
AUClast in plasma in single ascending dose administration
Area under the plasma drug concentration-time curve to last measurement
Measured: Baseline(Day 1) through Day 4
Eosinophil shape change(%) in single ascending dose administration
Imetit-induced eosinophil shape change
Measured: Baseline(Day -1) through Day 4
QT/QTc changes in single ascending dose administration
12-lead ECG
Measured: Baseline(Day -1), Day 1, Day 2
C(max, ss) in plasma in multiple ascending dose administration
Maximum concentration of drug in plasma (at steady state)
Measured: Baseline(Day 1) through Day 10
T(max,ss) in plasma in multiple ascending dose administration
Time to maximum plasma concentration (at steady state)
Measured: Baseline(Day 1) through Day 10
AUC(τ,ss) in plasma in multiple ascending dose administration
Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state
Measured: Baseline(Day 1) through Day 10
Eosinophil shape change(%) in multiple ascending dose administration
Imetit-induced eosinophil shape change
Measured: Baseline(Day -1) through Day 10
QT/QTc changes in multiple ascending dose administration
12-lead ECG
Measured: Baseline(Day -1), Day 7, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start15 Feb 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minsoo Park, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018170
- Sponsor's protocol ID
- JWP-FRC-101
- Status last verified
- Feb 2020
- First submitted
- 25 Mar 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase I Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of JW1601
- ClinicalTrials.gov ID
- NCT04018170
- Acronym / sponsor ID
- JWP-FRC-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 12 Jul 2019 (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 study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers
Detailed description
This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JW1601 | Experimental | Drug: Study drugtablet formulation |
| Placebo | Placebo comparator | Drug: Placebotablet formulation identified with JW1601 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study
Key exclusion criteria (1 listed)
- Subjects judged by the investigators unsuitable for participating in the study based on any other reasons
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 |
|---|---|---|
| Study drugAlso: JW1601oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg | Drug | JW1601 |
| Placebooral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets | Drug | Placebo |
Primary outcome
Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
Time frame: From Day 1 through Post Study Visit (Day 8)
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
Time frame: From Day 1 through Post Study Visit (Day 14)
AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.
10 secondary outcomes
Cmax in plasma in single ascending dose administration
Time frame: Baseline(Day 1) through Day 4
Tmax in plasma in single ascending dose administration
Time frame: Baseline(Day 1) through Day 4
AUClast in plasma in single ascending dose administration
Time frame: Baseline(Day 1) through Day 4
Eosinophil shape change(%) in single ascending dose administration
Time frame: Baseline(Day -1) through Day 4
QT/QTc changes in single ascending dose administration
Time frame: Baseline(Day -1), Day 1, Day 2
C(max, ss) in plasma in multiple ascending dose administration
Time frame: Baseline(Day 1) through Day 10
T(max,ss) in plasma in multiple ascending dose administration
Time frame: Baseline(Day 1) through Day 10
AUC(τ,ss) in plasma in multiple ascending dose administration
Time frame: Baseline(Day 1) through Day 10
Eosinophil shape change(%) in multiple ascending dose administration
Time frame: Baseline(Day -1) through Day 10
QT/QTc changes in multiple ascending dose administration
Time frame: Baseline(Day -1), Day 7, Day 8
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 13 Feb 2020.
- 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 Park, MD principal investigator
Severance Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Study drug in people with Healthy, run by JW Pharmaceutical at 2 sites 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 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring (time frame: From Day 1 through Post Study Visit (Day 8)). 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?
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 Feb 2020.