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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX-115 | Experimental | Participants will receive a single dose of PRX-115 by IV infusion |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of placebo by IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX-115 | Drug | Escalating doses of PRX-115 will be given in different cohorts i.e., Cohorts 1 through 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events receiving PRX-115 compared to placebo | 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 | Clinical laboratory tests include hematology, coagulation and biochemistry | Day 0 - Day 85 |
| Number of participants with abnormal clinical vital signs | 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 | Day 0 - Day 85 | |
| Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters | Day 0 - Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| PK of PRX-115: Maximum observed plasma drug concentration (Cmax) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Marshall, Dr. | New Zealand Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Grafton | Auckland | 1010 | New Zealand | ||
| New Zealand Clinical Research |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Placebo | Drug | Escalating doses of Placebo will be given in different cohorts i.e., Cohorts 1 through 8 |
|
|
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) | 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) | 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) | 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) | 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) | 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 | 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 | Day 1 - Day 85 |
| Christchurch |
| Christchurch |
| 8011 |
| New Zealand |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |