The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort. Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation. Part 3: An open-label, 2-period crossover FE assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
90
Nucleus Network Brisbane (Q-pharm)
Brisbane, Queensland, Australia
RECRUITINGNumber of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Time of the Maximum Measured Concentration (Tmax)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Volume of Distribution at Steady State (Vz/F)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Apparent Clearance (CL/F)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
Terminal Elimination Half-Life (t½el)
Time frame: Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)
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Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings
Time frame: From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])