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Safety and Tolerability Study of ARC-520 in Healthy Volunteers

NCT ID: NCT01872065

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARC-520

Single dose, intravenous administration of ARC-520.

Group Type EXPERIMENTAL

ARC-520

Intervention Type DRUG

Normal Saline

Single dose, intravenous administration of Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ARC-520

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Lickliter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Ltd

Locations

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Research Site 1

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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Heparc-1001

Identifier Type: -

Identifier Source: org_study_id