clinical trial · NCT05745727
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
Protalix·phase1·completed·n = 64
GoutPRX-115Placebo
brief summary
This is a Phase 1, double-blind, placebo-controlled, single ascending dose study in participants with elevated uric acid levels. This study will be conducted in approximately 64 adult male and female participants in the dose escalation phase.
started
Mar 23, 2023
primary completion
Aug 26, 2024
completion
Feb 6, 2025
last updated
Feb 11, 2025
detailed description
Participants will be assigned to 1 of 8 sequential dosing cohorts, each composed of 8 participants (6 active + 2 placebo) who will receive a single dose of PRX-115 or placebo by intravenous (IV) infusion.
official title
A Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol