A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteer… (NCT05745727) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
New Zealand64 participantsStarted 2023-03-23
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males or females 18 to 65 years of age, inclusive.
✓. Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
✓. Body mass index within the range 18.5 to 40 kg/m\^2, inclusive, at the Screening visit.
✓. Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
✓. Men and women of childbearing potential and their partners should use double barrier contraception.
Exclusion criteria
✕. Has any condition known to have arthritis as a clinical manifestation
✕. Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
✕. Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
✕. Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m\^2
✕. History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
✕. Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
✕. History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
What they're measuring
1
Number of participants with adverse events receiving PRX-115 compared to placebo
Timeframe: Day 0 - Day 85
2
Number of participants with abnormal clinically significant clinical laboratory results
Timeframe: Day 0 - Day 85
3
Number of participants with abnormal clinical vital signs
Timeframe: Day 0 - Day 85
4
Number of participants with abnormal clinically significant results from physical examination
Timeframe: Day 0 - Day 85
5
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters