A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

NCT04313205 | Unknown Phase 1 FDA Drug

• 1 other identifier: TWJ-SR122
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Adverse events (AEs) observed

  2 WEEKS

Study Arms (2)

Capsule

ACTIVE COMPARATOR

JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2

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

Drug: JKB-122 in capsule or tablet form

Interventions

JKB-122 in capsule or tablet form DRUG

JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form

Capsule; Tablet

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TaiwanJ Pharmaceuticals Co., Ltd: lead

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

JKB-122; Capsules

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Ying-Chu Shih, PhD

CONTACT

+886-36587721; info@taiwanj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 18, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share