Safety and Tolerability Study of ARC-520 in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: ARC-520

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Research Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Healthy male or female subjects, 18-55 years of age
• Be a non-smoker

Key Exclusion Criteria:

• History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment.
• Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.
• Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from screening.
• Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARC-520; Single dose, intravenous administration of ARC-520.	Drug: ARC-520
Placebo Comparator: Normal Saline; Single dose, intravenous administration of Normal Saline	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520	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.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the pharmacokinetics of ARC-520 at different dose concentrations	Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation.	2 days

Collaborators and Investigators

• Sponsor: Arrowhead Pharmaceuticals
• Investigators: Principal Investigator: Jason Lickliter, MD, PhD, Nucleus Network Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimated): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ARC-520
• Other Study ID Numbers: Heparc-1001