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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01872065




Registration number
NCT01872065
Ethics application status
Date submitted
4/06/2013
Date registered
7/06/2013
Date last updated
10/12/2014

Titles & IDs
Public title
Safety and Tolerability Study of ARC-520 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
Heparc-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARC-520
Treatment: Drugs - Placebo

Experimental: ARC-520 - Single dose, intravenous administration of ARC-520.

Placebo Comparator: Normal Saline - Single dose, intravenous administration of Normal Saline


Treatment: Drugs: ARC-520


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520
Timepoint [1] 0 0
One month
Secondary outcome [1] 0 0
To evaluate the pharmacokinetics of ARC-520 at different dose concentrations
Timepoint [1] 0 0
2 days

Eligibility
Key inclusion criteria
Key

- Healthy male or female subjects, 18-55 years of age

- Be a non-smoker

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
ARC-520 in normal, adult volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01872065
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD, PhD
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries