Conditions: Healthy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: yes

Brief summary:
Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.

Detailed description:
This is a single-center, open-label, sequential cohort, single-dose study of ARC-520 administered intravenously to healthy adult volunteers. Eligible subjects will receive a single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40 subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks including follow-up telephone calls at Days 30, 60 and 90.

Participants will undergo the following evaluations at regular intervals: medical history, physical examinations, bee venom allergy blood test, vital signs measurements, weight, adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females), concurrent medication, blood sample collection for hematology, coagulation, chemistry, pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.

Arms:
arm 1: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine arm 2: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine arm 3: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine arm 4: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine arm 5: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine arm 6: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine arm 7: Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine arm 8: Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine arm 9: Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine

Interventions: intervention 1: ARC-520 intervention 2: cetirizine intervention 3: diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: