NCT04313205

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: TaiwanJ Pharmaceuticals Co., Ltd · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Autoimmune Hepatitis

Interventions

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

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-03-18
• Last updated: 2020-07-15

Regulatory

• FDA-regulated drug study