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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since PRX-115 was tested in a Phase 1 trial focused mainly on safety and tolerability rather than effectiveness, what do the completed results tell us so far about whether it caused any serious side effects compared to placebo?
2This trial enrolled adults with elevated uric acid levels — given my own uric acid levels and gout history, would I even have been a candidate for a study like this, and does that tell us anything about how relevant its findings might be to my situation?
3Because this was an early Phase 1 study, there's still a long road before PRX-115 could become an approved treatment — are there any currently approved gout medications we should be trying first while this research continues to develop?
4The trial measured things like ECG changes and lab abnormalities as key safety signals — does anything in the published or reported results from this study raise any concerns about heart or organ-related effects that we should keep in mind?
5Are there any follow-on Phase 2 or Phase 3 trials of PRX-115 that might be recruiting, and would it be worth exploring whether I could participate in a later-stage study where more is known about both the safety and potential benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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