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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03365947
Ethics application status
Date submitted
4/12/2017
Date registered
8/12/2017

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
Other interventions - Sterile Normal Saline (0.9% NaCl)
Treatment: Drugs - JNJ-56136379

Experimental: ARO-HBV 35 mg - Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers

Experimental: ARO-HBV 100 mg - Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers

Experimental: ARO-HBV 200 mg - Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers

Experimental: ARO-HBV 300 mg - Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers

Experimental: ARO-HBV 400 mg - Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers

Placebo comparator: Placebo - Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers

Experimental: ARO-HBV 25 mg, Q28D - ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B

Experimental: ARO-HBV 50 mg Q28D - ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B

Experimental: ARO-HBV 100 mg Q28D - ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B

Experimental: ARO-HBV 200 mg Q28D - ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B

Experimental: ARO-HBV 300 mg Q28D - ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B

Experimental: ARO-HBV 400 mg Q28D - ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B

Experimental: ARO-HBV 100 mg Q14D - ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B

Experimental: ARO-HBV 100 mg Q7D - ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B

Experimental: ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve - ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B

Experimental: ARO-HBV 300 mg, Q28D, HBeAg+/ NUC - ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B

Experimental: ARO-HBV 200 mg, Q7D - ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B

Experimental: ARO-HBV 300 mg, Q7D - ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B

Experimental: ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg - ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B


Treatment: Drugs: ARO-HBV
sc injection

Other interventions: Sterile Normal Saline (0.9% NaCl)
sc injection

Treatment: Drugs: JNJ-56136379
oral tablets
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 Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
Timepoint [1] 0 0
NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)
Secondary outcome [1] 0 0
Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)
Timepoint [1] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [2] 0 0
Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)
Timepoint [2] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [3] 0 0
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)
Timepoint [3] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Secondary outcome [4] 0 0
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)
Timepoint [4] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [5] 0 0
Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Timepoint [5] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [6] 0 0
Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)
Timepoint [6] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [7] 0 0
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24
Timepoint [7] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Secondary outcome [8] 0 0
Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t
Timepoint [8] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [9] 0 0
Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax
Timepoint [9] 0 0
Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary outcome [10] 0 0
Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV
Timepoint [10] 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
* Hepatitis B surface antigen (HbsAg) at screening > or = 50 IU/mL
* Liver Elastography score < or = 10.5
Minimum age
18 Years
Maximum age
65 Years
Sex
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
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
27/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/04/2020
Sample size
Target
Accrual to date
Final
114
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
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?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03365947