The study consists of Part A, a randomized double-blind, single-ascending-dose study, and Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in healthy Japanese volunteers.
Part A includes the following two dose regimen groups: * 25 mg dose regimen group: ABX464 25 mg or placebo * 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Part B includes the following two dose regimen groups: * 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days * 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, Japan
Incidence of adverse events (AEs) and SAEs
number of incidences of all adverse events (AEs) (causally related and non-related) and SAEs, will be described further categorized by severity
Time frame: 6 weeks
incidence of treatment-emergent serious adverse events
number of incidences of treatment-emergent serious adverse events will be described
Time frame: 6 weeks
incidence of treatment-emergent adverse events of special interest (AESIs).
number of incidences of treatment-emergent adverse events of special interest (AESIs) will be described.
Time frame: 6 weeks
incidence of clinically significant laboratory abnormalities
number of incidences of clinically significant laboratory abnormalities will be described
Time frame: 6 weeks
Maximum Plasma Concentration [Cmax]
Cmax of ABX464 will be derived from the plasma concentrations
Time frame: 42 days
Area under the plasma concentration versus time curve (AUC)
AUC of ABX464 will be derived from the plasma concentrations
Time frame: 42 days
Time to reach the maximum plasma concentration (tmax)
Tmax of ABX464 will be derived from the plasma concentrations
Time frame: 42 days
miR124 level
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
concentration of miR124 expression will be measured in blood
Time frame: 42 days