The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form
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
Time frame: 2 WEEKS
Number of Adverse events (AEs) observed
Safety observation of the drug treatment.
Time frame: 2 WEEKS
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