A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
NCT ID: NCT05745727
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2023-03-23
2025-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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PRX-115
Participants will receive a single dose of PRX-115 by IV infusion
PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
Placebo
Participants will receive a single dose of placebo by IV infusion
Placebo
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
Interventions
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PRX-115
Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8
Placebo
Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Protalix
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Marshall, Dr.
Role: PRINCIPAL_INVESTIGATOR
New Zealand Clinical Research
Locations
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New Zealand Clinical Research
Grafton, Auckland, New Zealand
New Zealand Clinical Research
Christchurch, Christchurch, New Zealand
Countries
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Other Identifiers
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PB115-SAD-101
Identifier Type: -
Identifier Source: org_study_id
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