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Also known as MST-188, ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose
Vepoloxamer · 4 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| Study Drug | EXPERIMENTAL | MST-188 |
| MST-188 | EXPERIMENTAL | MST-188 injection administered as a continuous infusion 100 mg/kg for 1 hour followed by 30 mg/kg/hr for up to 48 hours. |
| Saline | PLACEBO_COMPARATOR | Saline administered as a continuous infusion for up to 49 hours |
| Cohort 1: Normal Renal Function | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 2: Mild Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 3: Moderate Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 4: Severe Renal Impairment | EXPERIMENTAL | Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours |
| Cohort 5: End Stage Renal Disease | EXPERIMENTAL | Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours |
| ANX-188 Therapeutic dose level | EXPERIMENTAL | IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours |
| ANX-188 Supratherapeutic dose | EXPERIMENTAL | IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours |
| Moxifloxacin | ACTIVE_COMPARATOR | Oral tablet. 400 mg. |
| Name | Type | Description |
|---|---|---|
| MST-188 | DRUG | Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours. |
| Saline | DRUG | - |
| Vepoloxamer | DRUG | - |
| ANX-188 Therapeutic Dose | DRUG | - |
| ANX-188 Supratherapeutic dose | DRUG | - |
| Moxifloxacin | DRUG | - |
Inclusion Criteria: * Completed participation in study MST-188-01 (EPIC study) * Subject age 4 through 65 years * Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia * Subject requires hospitalization Exclusion Criteria: * Subject has acute ch...
Vepoloxamer is a small molecule therapeutic candidate being developed by Savara, Inc. (ticker SVRA) in the nephrology therapeutic area. It is currently in Phase 1 clinical development. The specific indications being pursued have not been publicly disclosed.
Vepoloxamer is being developed by Savara, Inc., which trades on the Nasdaq under the ticker symbol SVRA. Savara is the sponsor of the clinical program for this small molecule candidate in the nephrology therapeutic area.
Vepoloxamer is in Phase 1 clinical development. It is an investigational drug candidate and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Vepoloxamer has been studied in one completed Phase 1 trial, NCT02646358, titled "Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer." The trial enrolled 27 participants in the United States and included healthy volunteers and renally impaired subjects.
NCT02646358 was a completed Phase 1 study evaluating the effect of renal impairment on the pharmacokinetics of Vepoloxamer. It was a controlled trial enrolling 27 participants aged 18 years and older in the United States, and it included healthy volunteers alongside renally impaired subjects.