Safety and Tolerability Study of ARC-520 in Healthy Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872065
• Other study ID #: Heparc-1001
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: December 9, 2014
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Arrowhead Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ARC-520

• Placebo

Locations

Country	Name	City	State
Australia	Nucleus Network Ltd.	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Research Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520	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.	One month	Yes
Secondary	To evaluate the pharmacokinetics of ARC-520 at different dose concentrations	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.	2 days	No