A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

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.

Study Overview

• Status: Unknown
• Conditions: Autoimmune Hepatitis
• Intervention / Treatment: Drug: JKB-122 in capsule or tablet form

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 Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 WEEKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse events (AEs) observed	Safety observation of the drug treatment.	2 WEEKS

Collaborators and Investigators

• Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Chronic; Hepatitis; Hepatitis, Autoimmune
• Other Study ID Numbers: TWJ-SR122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No