Safety and Tolerability Study of ARC-520 in Healthy Volunteers

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

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
• Actual Primary Completion Date: September 2014
• Actual 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

• 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

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
• Other Study ID Numbers: Heparc-1001
• First Posted: June 7, 2013
• Last Update Posted: December 10, 2014
• Last Verified: December 2014