The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03365947




Registration number
NCT03365947
Ethics application status
Date submitted
4/12/2017
Date registered
4/12/2017
Date last updated
8/01/2019

Titles & IDs
Public title
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Scientific title
A Phase 1/2a Single Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-HBV in Normal Adult Volunteers and Multiple Escalating Doses Evaluating Safety, Tolerability and Pharmacodynamic Effects in HBV Patients
Secondary ID [1] 0 0
AROHBV1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-HBV Injection
Other interventions - Sterile Normal Saline (0.9% NaCl)

Active Comparator: ARO-HBV Injection -

Placebo Comparator: Placebo -


Treatment: Drugs: ARO-HBV Injection
Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection

Other interventions: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment
Timepoint [1] 0 0
Up to 203 days
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of ARO-HBV: Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Part A (single-ascending dose [SAD] phase) only: up to 48 hours post-dose
Secondary outcome [2] 0 0
PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax)
Timepoint [2] 0 0
Part A (SAD phase) only: up to 48 hours post-dose
Secondary outcome [3] 0 0
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Timepoint [3] 0 0
Part A (SAD phase) only: up to 48 hours post-dose
Secondary outcome [4] 0 0
PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Timepoint [4] 0 0
Part A (SAD phase) only: up to 48 hours post-dose
Secondary outcome [5] 0 0
PK of ARO-HBV: Terminal Elimination Half-Life (t½)
Timepoint [5] 0 0
Part A (SAD phase) only: up to 48 hours post-dose
Secondary outcome [6] 0 0
Reduction of HBV Surface Antigen (HBsAg) from Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV
Timepoint [6] 0 0
Part B (multiple-ascending dose [MAD] phase) only: up to 113 days

Eligibility
Key inclusion criteria
Inclusion Criteria for Parts A & B:

- Women of childbearing potential must have a negative pregnancy test, cannot be breast
feeding, and must be willing to use contraception.

- Willing to provide written informed consent and comply with study requirements

Additional Inclusion Criteria for Part B:

- Diagnosis of chronic HBV infection

- HbsAg at screening > or = 50 IU/mL

- Liver Elastography score < or = 10.5
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinically significant health concerns (with the exception of HBV for Patients in Part
B)

- Abnormal for any clinical safety laboratory result considered clinically significant

- Regular use of alcohol within 1 month prior to screening

- Recent use of illicit drugs

- Use of an investigational agent or device within 30 days prior to dosing or current
participation in an investigational study

NOTE: additional inclusion/exclusion criteria may apply, per protocol

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Linear Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

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, pharmacokinetics and
pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult
volunteers and participants with hepatitis B virus (HBV).
Trial website
https://clinicaltrials.gov/show/NCT03365947
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
James Hamilton, MD
Address 0 0
Country 0 0
Phone 0 0
626-304-3400
Fax 0 0
Email 0 0
jhamilton@arrowheadpharma.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable