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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02535416




Registration number
NCT02535416
Ethics application status
Date submitted
24/08/2015
Date registered
28/08/2015

Titles & IDs
Public title
A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
Scientific title
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 at Varying Infusion Rates in Normal Adult Volunteers
Secondary ID [1] 0 0
Heparc-1002
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
Experimental: ARC-520 Cohort 1 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine

Experimental: ARC-520 Cohort 2A - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine

Experimental: ARC-520 Cohort 2 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine

Experimental: ARC-520 Cohort 3 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine

Experimental: ARC-520 Cohort 4 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine

Experimental: ARC-520 Cohort 5 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine

Experimental: ARC-520 Cohort 6 - Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine

Experimental: ARC-520 Cohort 7 - Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine

Experimental: ARC-520 Cohort 8 - Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
post-dose through the end of study (Day 15 ± 1 day) plus 30 days
Secondary outcome [1] 0 0
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520
Timepoint [1] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [2] 0 0
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520
Timepoint [2] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [3] 0 0
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520
Timepoint [3] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [4] 0 0
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520
Timepoint [4] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [5] 0 0
Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520
Timepoint [5] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [6] 0 0
Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520
Timepoint [6] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [7] 0 0
Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520
Timepoint [7] 0 0
Day 1 pre-dose through 48 hours post-dose
Secondary outcome [8] 0 0
Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520
Timepoint [8] 0 0
Day 1 pre-dose through 48 hours post-dose

Eligibility
Key inclusion criteria
* Male or female, 18-55 years of age, inclusive
* Able to provide written informed consent
* BMI between 19.0 and 35.0 kg/m2, inclusive
* 12-lead ECG at Screening and pre-dose with no clinically significant abnormalities
* Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the dose of ARC-520
* Willing and able to comply with all study assessments
* Suitable venous access for blood sampling
* Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and creatinine levels in the normal range
* No abnormal finding of clinical relevance
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant/lactating
* Acute signs of hepatitis/other infection within 4 weeks of Screening
* Concurrent use of anticoagulants, corticosteroids, immunomodulators, or immunosuppressants.
* Use of prescription medication within 14 days prior to study treatment
* Depot injection/implant other than birth control within 3 months of study treatment
* Known diagnosis of diabetes mellitus
* History of autoimmune disease especially autoimmune hepatitis.
* Human immunodeficiency virus (HIV) infection
* Sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Uncontrolled hypertension: blood pressure (BP) > 150/100 mmHg
* History of cardiac rhythm disturbances
* Family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
* Currently uses medications known to prolong the corrected QT interval (QTc).
* Symptomatic heart failure (per New York Heart Association guidelines)
* Unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within past 6 months
* History of malignancy within last 5 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
* Major surgery within 3 months of Screening
* History of alcohol and/or drug abuse < 12 months from Screening
* Regular use of alcohol within 6 months of Screening
* Evidence of systemic acute inflammation, sepsis or hemolysis.
* Clinically significant psychiatric disorder
* Use of recreational drugs within 3 months of Screening or drugs, such as cocaine, phencyclidine (PCP), and methamphetamines, within 1 year of Screening
* Positive urine drug screen
* History of allergy or hypersensitivity reaction to bee venom
* Positive reaction to the bee venom immunoglobulin E [IgE] test
* Use of investigational agents or devices within 30 days of study dosing or current participation in an investigational study.
* Clinically significant history/presence of any gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease
* Cholangitis, cholecystitis, cholestasis, or duct obstruction
* Clinically significant history/presence of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, metabolic or other uncontrolled systemic disease
* Blood donation or blood loss (500 mL) within 30 days prior to study treatment
* History of fever within 2 weeks of Screening.
* Excessive exercise/physical activity within 7 days of Screening or enrollment or planned during the study.
* History of coagulopathy, stroke within six (6) months of baseline, and/or concurrent anticoagulant medication(s)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QPharm, Pty Limited, Royal Brisbane Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02535416