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

NCT02535416 | Completed Phase 1 Results

• 1 other identifier: Heparc-1002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  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.

  post-dose through the end of study (Day 15 ± 1 day) plus 30 days

Secondary Outcomes (8)

• Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520

  Day 1 pre-dose through 48 hours post-dose

• Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520

  Day 1 pre-dose through 48 hours post-dose

• Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520

  Day 1 pre-dose through 48 hours post-dose

• Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520

  Day 1 pre-dose through 48 hours post-dose

• Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520

  Day 1 pre-dose through 48 hours post-dose

Study Arms (9)

ARC-520 Cohort 1

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine

Drug: ARC-520; Drug: cetirizine

ARC-520 Cohort 2A

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine

Drug: ARC-520; Drug: cetirizine

ARC-520 Cohort 2

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 3

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 4

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 5

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 6

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 7

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

ARC-520 Cohort 8

EXPERIMENTAL

Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine

Drug: ARC-520; Drug: diphenhydramine

Interventions

ARC-520 DRUG

ARC-520 Cohort 1; ARC-520 Cohort 2; ARC-520 Cohort 2A; ARC-520 Cohort 3; ARC-520 Cohort 4; ARC-520 Cohort 5; ARC-520 Cohort 6; ARC-520 Cohort 7; ARC-520 Cohort 8

cetirizine DRUG

ARC-520 Cohort 1; ARC-520 Cohort 2A

diphenhydramine DRUG

ARC-520 Cohort 2; ARC-520 Cohort 3; ARC-520 Cohort 4; ARC-520 Cohort 5; ARC-520 Cohort 6; ARC-520 Cohort 7; ARC-520 Cohort 8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• lead ECG at Screening and pre-dose with no clinically significant abnormalities
• Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the dose of ARC-520
• Willing and able to comply with all study assessments
• Suitable venous access for blood sampling
• Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and creatinine levels in the normal range
• No abnormal finding of clinical relevance

You may not qualify if:

• Pregnant/lactating
• Acute signs of hepatitis/other infection within 4 weeks of Screening
• Concurrent use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
• Use of prescription medication within 14 days prior to study treatment
• Depot injection/implant other than birth control within 3 months of study treatment
• Known diagnosis of diabetes mellitus
• History of autoimmune disease especially autoimmune hepatitis.
• Human immunodeficiency virus (HIV) infection
• Sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Uncontrolled hypertension: blood pressure (BP) \> 150/100 mmHg
• History of cardiac rhythm disturbances
• Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
• Currently uses medications known to prolong the corrected QT interval (QTc).
• Symptomatic heart failure (per New York Heart Association guidelines)
• Unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within past 6 months

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Herston, Queensland, 4029, Australia

Location

MeSH Terms

Interventions

ARC-520; Cetirizine; Diphenhydramine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: James Hamilton, MD
• Organization: Arrowhead Pharmaceuticals, Inc.

jhamilton@arrowheadpharma.com

626-696-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 28, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 13, 2026
• Results First Posted: February 26, 2018

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)