HealthyPhase 1NCT02535416
A Study of ARC-520 at Varying Infusion Rates in Healthy Adult Volunteers
A Phase 1 study testing ARC-520, cetirizine and diphenhydramine in people with Healthy, run by Arrowhead Pharmaceuticals at 1 site in Australia.
Trial summary
Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ARC-520, cetirizine and diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.
Read the detailed description
This is a single-center, open-label, sequential cohort, single-dose study of ARC-520 administered intravenously to healthy adult volunteers. Eligible subjects will receive a single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40 subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks including follow-up telephone calls at Days 30, 60 and 90.
Participants will undergo the following evaluations at regular intervals: medical history, physical examinations, bee venom allergy blood test, vital signs measurements, weight, adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females), concurrent medication, blood sample collection for hematology, coagulation, chemistry, pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.
- Conditions
- Healthy
- Being tested
- ARC-520, cetirizine, diphenhydramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-520Drug
cetirizineDrug
diphenhydramineDrug
| Study group | Role | What they receive |
|---|---|---|
| ARC-520 Cohort 1 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.6 mL/min + cetirizine Receives: Drug: ARC-520; Drug: cetirizine |
| ARC-520 Cohort 2A | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + cetirizine Receives: Drug: ARC-520; Drug: cetirizine |
| ARC-520 Cohort 2 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.75 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 3 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 0.9 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 4 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.2 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 5 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 1.5 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 6 | Experimental | Single dose, intravenous administration of ARC-520 at 4.0 mg/kg 5 minute slow bolus push + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 7 | Experimental | Single dose, intravenous administration of ARC-520 at 5.0 mg/kg 0.9 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
| ARC-520 Cohort 8 | Experimental | Single dose, intravenous administration of ARC-520 at 6.0 mg/kg 0.9 mL/min + diphenhydramine Receives: Drug: ARC-520; Drug: diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.
Measured: post-dose through the end of study (Day 15 ± 1 day) plus 30 days
Secondary outcomes (8)
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus [HBV]) and melittin-like peptide (MLP).
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520
Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.
Measured: Day 1 pre-dose through 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535416
- Sponsor's protocol ID
- Heparc-1002
- Status last verified
- Dec 2025
- First submitted
- 24 Aug 2015
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No