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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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.

NCT05745727•Protalix

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females 18 to 65 years of age, inclusive.
•2. Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
•3. Body mass index within the range 18.5 to 40 kg/m\^2, inclusive, at the Screening visit.
•4. Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
•5. Men and women of childbearing potential and their partners should use double barrier contraception.

Exclusion Criteria

•1. Has any condition known to have arthritis as a clinical manifestation
•2. Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
•3. Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
•4. Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m\^2
•5. History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
•6. Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
•7. History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
•8. Has evidence of cardiovascular or cerebrovascular disease.
•9. History of congestive heart failure, New York Heart Association Class III or IV.
•10. BP outside the range of 90 to 150 mm Hg for systolic or 50 to 95 mm Hg for diastolic.
+5 more criteria

Locations (2)

New Zealand Clinical Research

Grafton, Auckland, New Zealand

New Zealand Clinical Research

Christchurch, Christchurch, New Zealand

Key Dates

Start Date

March 23, 2023

Primary Completion Date

August 26, 2024

Completion Date

February 6, 2025

Last Updated

February 11, 2025

Enrollment

ACTUAL participants

Conditions

Gout

Interventions

PRX-115

DRUG

Placebo

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

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