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Also known as ARC-520 Injection
ARC-520 · 2 trials · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.
The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.
| Arm | Type | Description |
|---|---|---|
| ARC-520 Cohort 1 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine |
| ARC-520 Cohort 2A | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine |
| ARC-520 Cohort 2 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine |
| ARC-520 Cohort 3 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine |
| ARC-520 Cohort 4 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine |
| ARC-520 Cohort 5 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine |
| ARC-520 Cohort 6 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine |
| ARC-520 Cohort 7 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine |
| ARC-520 Cohort 8 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine |
| ARC-520 | EXPERIMENTAL | Single dose, intravenous administration of ARC-520. |
| Normal Saline | PLACEBO_COMPARATOR | Single dose, intravenous administration of Normal Saline |
| Name | Type | Description |
|---|---|---|
| ARC-520 | DRUG | - |
| cetirizine | DRUG | - |
| diphenhydramine | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or female, 18-55 years of age, inclusive * Able to provide written informed consent * BMI between 19.0 and 35.0 kg/m2, inclusive * 12-lead ECG at Screening and pre-dose with no clinically significant abnormalities * Highly effective, double barrier contraception (both mal...
ARC-520 is an investigational small molecule developed by Arrowhead Pharmaceuticals, Inc. (ticker ARWR). It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific disease indications for ARC-520 have not been disclosed.
ARC-520 is being developed by Arrowhead Pharmaceuticals, Inc., which trades under the ticker symbol ARWR. The company sponsored the Phase 1 clinical trials of ARC-520 conducted in Australia.
ARC-520 is in Phase 1 clinical development. Both of its Phase 1 trials have been completed, and there are currently no active trials. The drug remains investigational and has not been approved by the FDA.
ARC-520 has been evaluated in two completed Phase 1 trials. NCT02535416 studied ARC-520 at varying infusion rates in 40 healthy adult volunteers in Australia. NCT01872065 was a safety and tolerability study in 54 healthy volunteers, also in Australia. Both trials enrolled adults aged 18 and older.
No. ARC-520 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its two Phase 1 trials, which together enrolled 94 healthy volunteers, have been completed.
ARC-520 is an investigational drug that has been studied in Phase 1 clinical trials involving healthy adult volunteers. Its intended therapeutic indications have not been disclosed, so its specific use in treating disease is not publicly defined.