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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05745727
Registration number
NCT05745727
Ethics application status
Date submitted
3/02/2023
Date registered
27/02/2023
Date last updated
14/05/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
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Scientific 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.
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Secondary ID [1]
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PB115-SAD-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRX-115
Treatment: Drugs - Placebo
Experimental: PRX-115 - Participants will receive a single dose of PRX-115 by IV infusion
Placebo Comparator: Placebo - Participants will receive a single dose of placebo by IV infusion
Treatment: Drugs: PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
Treatment: Drugs: Placebo
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with adverse events receiving PRX-115 compared to placebo
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Assessment method [1]
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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.
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Timepoint [1]
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Day 0 - Day 85
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Primary outcome [2]
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Number of participants with abnormal clinically significant clinical laboratory results
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Assessment method [2]
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Clinical laboratory tests include hematology, coagulation and biochemistry
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Timepoint [2]
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Day 0 - Day 85
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Primary outcome [3]
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Number of participants with abnormal clinical vital signs
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Assessment method [3]
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Vital signs include pulse rate, blood pressure, respiratory rate and tympanic temperature
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Timepoint [3]
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Day 0 - Day 85
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Primary outcome [4]
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Number of participants with abnormal clinically significant results from physical examination
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Assessment method [4]
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Timepoint [4]
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Day 0 - Day 85
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Primary outcome [5]
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Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
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Assessment method [5]
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Timepoint [5]
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Day 0 - Day 85
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Secondary outcome [1]
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PK of PRX-115: Maximum observed plasma drug concentration (Cmax)
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Assessment method [1]
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The Cmax PK parameter calculated based on the observed plasma drug concentration versus time curve
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Timepoint [1]
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Day 1 - Day 85
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Secondary outcome [2]
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PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-t)
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Assessment method [2]
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The PK parameter calculated will be Area under the plasma drug concentration-time curve of the last measurable drug concentration (AUC0-t).
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Timepoint [2]
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Day 1 - Day 85
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Secondary outcome [3]
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PK of PRX-115: Time to maximum observed plasma drug concentration (Tmax)
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Assessment method [3]
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The PK parameter calculated will be Time to maximum observed plasma drug concentration (T max).
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Timepoint [3]
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Day 1 - Day 85
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Secondary outcome [4]
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PK of PRX-115: total body clearance (CL)
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Assessment method [4]
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The PK parameter calculated will be total body clearance (CL).
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Timepoint [4]
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Day 1 - Day 85
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Secondary outcome [5]
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PK of PRX-115: volume of distribution during the terminal phase (Vd)
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Assessment method [5]
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The PK parameter calculated will be volume of distribution during the terminal phase (Vd).
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Timepoint [5]
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Day 1 - Day 85
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Secondary outcome [6]
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PK of PRX-115: Terminal elimination half-life (T ½)
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Assessment method [6]
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The PK parameter of Terminal elimination half-life (T ½) is calculated based on the plasma drug concentration-time curve
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Timepoint [6]
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Day 1 - Day 85
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Secondary outcome [7]
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PK of PRX-115: Area under the plasma concentration versus time curve (AUC 0-inf)
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Assessment method [7]
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The PK parameters calculated will be Area under the plasma drug concentration-time curve from time 0 to infinity (AUC0-inf).
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Timepoint [7]
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Day 1 - Day 85
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Secondary outcome [8]
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Pharmacodynamics of PRX-115: blood uric acid levels
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Assessment method [8]
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Pharmacodynamics of PRX-115 by measurement of blood uric acid levels over 85 days
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Timepoint [8]
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Day 0 - Day 85
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Secondary outcome [9]
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Immunogenicity of PRX-115: measurement of anti-drug antibody levels
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Assessment method [9]
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Timepoint [9]
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Day 1 - Day 85
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Eligibility
Key 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 (ß-hCG) test result at Screening.
5. Men and women of childbearing potential and their partners should use double barrier
contraception.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Protalix
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05745727
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mark Marshall, Dr.
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Address
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New Zealand Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Orit Cohen-Barak, PhD
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Address
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Country
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Phone
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+972-4-9052-8100
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05745727
Download to PDF