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Completed

NCT Number: NCT01872065

Safety and Tolerability Study of ARC-520 in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site 1

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARC-520

Drug

Placebo

Drug

Primary outcomes

  1. To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520

    Time frame: One month

    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.

Secondary outcomes

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

    Time frame: 2 days

    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.

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2013
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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