Safety and Tolerability Study of ARC-520 in Healthy Volunteers

NCT01872065 | Completed Phase 1

• 1 other identifier: Heparc-1001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the pharmacokinetics of ARC-520 at different dose concentrations

  2 days

Study Arms (2)

ARC-520

EXPERIMENTAL

Single dose, intravenous administration of ARC-520.

Drug: ARC-520

Normal Saline

PLACEBO COMPARATOR

Single dose, intravenous administration of Normal Saline

Drug: Placebo

Interventions

ARC-520 DRUG

ARC-520

Placebo DRUG

Normal Saline

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Interventions

ARC-520

Study Officials

• Jason Lickliter, MD, PhD

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

AU (1)