Autoimmune HepatitisPhase 1NCT04313205
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
A Phase 1 study testing JKB-122 in capsule or tablet form in people with Autoimmune Hepatitis, run by TaiwanJ Pharmaceuticals Co., Ltd.
Trial summary
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- JKB-122 in capsule or tablet form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2020
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg.
- Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
- The subject provided written informed consent.
Who cannot join
- Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
- Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
- Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
- Current smoker or history of smoking within 3 months before the Screening Visit.
- History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
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- Any use of drugs-of-abuse within 3 months before the Screening Visit.
- Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
- Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
- Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
- The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
Read the detailed description
This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.
- Conditions
- Autoimmune Hepatitis
- Being tested
- JKB-122 in capsule or tablet form
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKB-122 in capsule or tablet formDrug
JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form
| Study group | Role | What they receive |
|---|---|---|
| Capsule | Active comparator | JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2 Receives: Drug: JKB-122 in capsule or tablet form |
| Tablet | Active comparator | JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2 Receives: Drug: JKB-122 in capsule or tablet form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)
Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet
Measured: 2 WEEKS
Secondary outcomes (1)
Number of Adverse events (AEs) observed
Safety observation of the drug treatment.
Measured: 2 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313205
- Sponsor's protocol ID
- TWJ-SR122
- Status last verified
- Jul 2020
- First submitted
- 16 Mar 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04313205
- Acronym / sponsor ID
- TWJ-SR122
- Conditions
- Autoimmune Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Mar 2020 (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 purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
Detailed description
This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsule | Active comparator | Drug: JKB-122 in capsule or tablet formJKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2 |
| Tablet | Active comparator | Drug: JKB-122 in capsule or tablet formJKB-122 tablet on period 1 followed by JKB-122 capsule on period 2 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg.
- Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
- The subject provided written informed consent.
Key exclusion criteria (11 listed)
- Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
- Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
- Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
- Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
- Current smoker or history of smoking within 3 months before the Screening Visit.
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 |
|---|---|---|
| JKB-122 in capsule or tablet formJKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form | Drug | Capsule, Tablet |
Primary outcome
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)
Time frame: 2 WEEKS
Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet
1 secondary outcome
Number of Adverse events (AEs) observed
Time frame: 2 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JKB-122 in capsule or tablet form in people with Autoimmune Hepatitis, run by TaiwanJ Pharmaceuticals Co., Ltd.
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 11 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Chu Shih, PhD (+886-36587721, info@taiwanj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬) (time frame: 2 WEEKS). 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 15 Jul 2020.