This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
36
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)
PRA Health Sciences - Early Development Services
Groningen, Netherlands
Number of subjects with adverse events
Time frame: Day 19
Part 1: AUC0-tau
Time frame: Days 1-2
Part 2: AUC0-tau
Time frame: Days 3-12
Part 1: Cmax
Time frame: Days 1-2
Part 2: Cmax
Time frame: Days 3-12
Part 1: tmax
Time frame: Days 1-2
Part 2: tmax
Time frame: Days 3-12
Part 1: CLr
Time frame: Days 1-2
Part 2: CLr
Time frame: Days 3-12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.