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Also known as vepoloxamer
ANX-188 Therapeutic Dose · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| 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 |
| Saline | PLACEBO_COMPARATOR | IV administration. Six hour infusion. |
| Moxifloxacin | ACTIVE_COMPARATOR | Oral tablet. 400 mg. |
| Name | Type | Description |
|---|---|---|
| Vepoloxamer | DRUG | - |
| ANX-188 Therapeutic Dose | DRUG | - |
| ANX-188 Supratherapeutic dose | DRUG | - |
| Saline | DRUG | - |
| Moxifloxacin | DRUG | - |
Key Inclusion Criteria: * Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2 * Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days * If female, subject must not be pregnant or lactating, have a negative pregnan...
ANX-188 Therapeutic Dose is an investigational small molecule developed by Savara, Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. No therapeutic indication for the drug has been disclosed, and it remains in clinical development rather than being an approved medicine.
ANX-188 Therapeutic Dose is being developed by Savara, Inc., which trades on the Nasdaq under the ticker symbol SVRA. Savara sponsored the Phase 1 study of the compound conducted in the United States.
ANX-188 Therapeutic Dose is in Phase 1 development. Its only recorded clinical trial, NCT01790087, was a Phase 1 thorough QT/QTc study that has been completed. The drug is investigational and has not been approved for any use.
ANX-188 Therapeutic Dose has been evaluated in one clinical trial, NCT01790087, titled ANX-188 Thorough QT/QTc Study in Healthy Volunteers. The Phase 1 trial was completed, enrolled 72 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States with healthy volunteers aged 18 years and older.
NCT01790087 was a completed Phase 1 thorough QT/QTc study of ANX-188 Therapeutic Dose in healthy volunteers. It enrolled 72 participants of all sexes, aged 18 years and older, in the United States. The study was randomized, double blind, and placebo controlled.