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A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers

Healthy Clinical Trial

Official title:
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 at Varying Infusion Rates in Normal Adult Volunteers

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02535416
Study type Interventional
Source Arrowhead Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date September 2015
Completion date August 2016
View Details
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