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

February 9, 2025 updated by: Protalix

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8011
        • New Zealand Clinical Research
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • New Zealand Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  11. Participants with hypertension who are not on stable medication for at least 6 months.
  12. Has uncontrolled type 2 diabetes
  13. Concurrent treatment with urate lowering drugs (ULDs).
  14. Prior exposure to any experimental or marketed uricase (eg, rasburicase [Elitek, Fasturtec], pegloticase [Krystexxa®], pegadricase [SEL-212]).
  15. Glucose-6-phosphate dehydrogenase (G6PD) deficiency or known catalase deficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PRX-115
Participants will receive a single dose of PRX-115 by IV infusion
Drug: PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
Other Names:
  • Escalating doses of PRX-115
Placebo Comparator: Placebo
Participants will receive a single dose of placebo by IV infusion
Drug: Placebo
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
Other Names:
  • Placebo to match

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events receiving PRX-115 compared to placebo
Time Frame: Day 0 - Day 85
To assess the safety and tolerability of a single infusion of PRX-115 as assessed by frequency of drug related adverse events, graded by severity.
Day 0 - Day 85
Number of participants with abnormal clinically significant clinical laboratory results
Time Frame: Day 0 - Day 85
Clinical laboratory tests include hematology, coagulation and biochemistry
Day 0 - Day 85
Number of participants with abnormal clinical vital signs
Time Frame: Day 0 - Day 85
Vital signs include pulse rate, blood pressure, respiratory rate and tympanic temperature
Day 0 - Day 85
Number of participants with abnormal clinically significant results from physical examination
Time Frame: Day 0 - Day 85
Day 0 - Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time Frame: Day 0 - Day 85
Day 0 - Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
Time Frame: Day 1 - Day 85
The Cmax PK parameter calculated based on the observed plasma drug concentration versus time curve
Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
Time Frame: Day 1 - Day 85
The PK parameter calculated will be Area under the plasma drug concentration-time curve of the last measurable drug concentration (AUC0-t).
Day 1 - Day 85
PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
Time Frame: Day 1 - Day 85
The PK parameter calculated will be Time to maximum observed plasma drug concentration (T max).
Day 1 - Day 85
PK of PRX-115: total body clearance (CL)
Time Frame: Day 1 - Day 85
The PK parameter calculated will be total body clearance (CL).
Day 1 - Day 85
PK of PRX-115: volume of distribution during the terminal phase (Vd)
Time Frame: Day 1 - Day 85
The PK parameter calculated will be volume of distribution during the terminal phase (Vd).
Day 1 - Day 85
PK of PRX-115: Terminal elimination half-life (T ½)
Time Frame: Day 1 - Day 85
The PK parameter of Terminal elimination half-life (T ½) is calculated based on the plasma drug concentration-time curve
Day 1 - Day 85
PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
Time Frame: Day 1 - Day 85
The PK parameters calculated will be Area under the plasma drug concentration-time curve from time 0 to infinity (AUC0-inf).
Day 1 - Day 85
Pharmacodynamics of PRX-115: blood uric acid levels
Time Frame: Day 0 - Day 85
Pharmacodynamics of PRX-115 by measurement of blood uric acid levels over 85 days
Day 0 - Day 85
Immunogenicity of PRX-115: measurement of anti-drug antibody levels
Time Frame: Day 1 - Day 85
Day 1 - Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Protalix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Marshall, Dr., New Zealand Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB115-SAD-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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