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A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04313205
Recruitment Status : Not yet recruiting
First Posted : March 18, 2020
Last Update Posted : July 15, 2020
Information provided by (Responsible Party):
TaiwanJ Pharmaceuticals Co., Ltd

Brief Summary:
The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: JKB-122 in capsule or tablet form Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Capsule
JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2
Drug: JKB-122 in capsule or tablet form
JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form

Active Comparator: Tablet
JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2
Drug: JKB-122 in capsule or tablet form
JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Number of Adverse events (AEs) observed [ Time Frame: 2 WEEKS ]
    Safety observation of the drug treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg.
  2. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
  3. The subject provided written informed consent.

Exclusion Criteria:

  1. Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
  2. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
  3. 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.
  4. 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.
  5. Current smoker or history of smoking within 3 months before the Screening Visit.
  6. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
  7. Any use of drugs-of-abuse within 3 months before the Screening Visit.
  8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
  9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
  10. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
  11. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04313205

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Contact: Ying-Chu Shih, PhD +886-36587721

Sponsors and Collaborators
TaiwanJ Pharmaceuticals Co., Ltd
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Responsible Party: TaiwanJ Pharmaceuticals Co., Ltd Identifier: NCT04313205    
Other Study ID Numbers: TWJ-SR122
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases