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Safety and Tolerability Study of ARC-520 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01872065
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ARC-520 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2013
Primary Completion Date : September 2014
Study Completion Date : November 2014
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872065


Locations
Australia, Victoria
Nucleus Network Ltd.
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Arrowhead Pharmaceuticals
Investigators
Principal Investigator: Jason Lickliter, MD, PhD Nucleus Network Ltd
More Information

Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01872065     History of Changes
Other Study ID Numbers: Heparc-1001
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014