Safety and Tolerability Study of ARC-520 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ARC-520; Drug: Placebo

• Registration Number: NCT01872065
• Lead Sponsor: Arrowhead Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Study Start: 2013-07
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Key

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARC-520	ARC-520	Single dose, intravenous administration of ARC-520.
Normal Saline	Placebo	Single dose, intravenous administration of Normal Saline

Primary Outcome Measures

Name	Time	Method
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520	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

Name	Time	Method
To evaluate the pharmacokinetics of ARC-520 at different dose concentrations	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.

Trial Locations

Locations (1)

Nucleus Network Ltd.; 🇦🇺 Melbourne, Victoria, Australia