NCT05745727

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Protalix · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	PRX-115	Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
DRUG	Placebo	Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8

Timeline

• Start date: 2023-03-23
• Primary completion: 2024-08-26
• Completion: 2025-02-06
• First posted: 2023-02-27
• Last updated: 2025-02-11

Locations

2 sites across 1 country: New Zealand