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A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels

Gout Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05745727
Study type Interventional
Source Protalix
Contact Orit Cohen-Barak, PhD
Phone +972-4-9052-8100
Email Orit.Barak@protalix.com
Status Recruiting
Phase Phase 1
Start date March 23, 2023
Completion date December 2024
View Details
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