Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being studied in healthy volunteers. It is being evaluated for safety and tolerability in Phase 1 clinical trials. The drug is not approved for any condition and remains in clinical development.
ARC-520 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARWR. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
ARC-520 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy adult volunteers. The drug is investigational and has not been approved by regulatory authorities.
ARC-520 has been studied in two completed Phase 1 trials. The first, NCT01872065, assessed safety and tolerability in 54 healthy volunteers in Australia. The second, NCT02535416, evaluated varying infusion rates in 40 healthy adult volunteers, also in Australia.
Yes, ARC-520 is classified as a small molecule drug. It is being studied in healthy volunteers to assess its safety and tolerability, with two completed Phase 1 trials involving a total of 94 participants.