Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02535416 | A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers | PHASE1 | COMPLETED | 40 | — | — | Sep 1, 2015 | Aug 1, 2016 | Jan 13, 2026 | 1 | Australia |
| NCT01872065 | Safety and Tolerability Study of ARC-520 in Healthy Volunteers | PHASE1 | COMPLETED | 54 | — | — | Jul 1, 2013 | Nov 1, 2014 | Dec 26, 2025 | 1 | Australia |
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...