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Renazorb/day · 1 trial · 2 indications
Efficacy will be evaluated by comparing difference in urine and fecal phosphorous excretion before and after treatment.
| Arm | Type | Description |
|---|---|---|
| Group B | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Group C | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Group D | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
| Group A | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Name | Type | Description |
|---|---|---|
| Renazorb 1500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 3000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Renazorb 4500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 6000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
Inclusion Criteria: * Healthy male and female volunteers ≥ 18 years of age without history of significant medical disease will be enrolled. Exclusion Criteria:
Renazorb/day is an investigational small molecule developed by Assertio Holdings, Inc. (ticker ASRT). It was studied in a Phase 1 trial evaluating safety and phosphate binding capacity. The trial enrolled 32 healthy adult volunteers in the United States and has been completed. Renazorb/day is also known as Renazorb 1500 mg/day.
Renazorb/day was studied for safety and phosphate binding capacity in a Phase 1 clinical trial. The completed study enrolled 32 healthy adult volunteers and assessed the drug's phosphate binding capacity alongside its safety profile. It is an investigational agent and has not been approved for any indication.
Renazorb/day is developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company sponsored the Phase 1 study of the drug. Assertio Holdings is the developer associated with this asset.
Renazorb/day is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Renazorb/day has been evaluated in one completed Phase 1 trial, NCT01560884, titled "Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb." The randomized, double-blind, active-controlled study enrolled 32 healthy adult volunteers in the United States. No active trials are currently listed.