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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

NCT05745727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Protalix

    lead INDUSTRY

Principal Investigators

  • Mark Marshall, Dr. · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2024-08-26
Completion
2025-02-06

Countries

  • New Zealand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05745727 on ClinicalTrials.gov