Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)

Arrowhead Pharmaceuticals114 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Hepatitis B

Interventions

ARO-HBVDRUG

sc injection

Sterile Normal Saline (0.9% NaCl)OTHER

sc injection

JNJ-56136379DRUG

oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (7)

Research Site 5

Camperdown, New South Wales, Australia

Research Site 4

Clayton, Victoria, Australia

Research Site 3

Melbourne, Victoria, Australia

Research Site 6

Nedlands, Western Australia, Australia

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment

An adverse event (AE) is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. Assessment of causality utilized 3 possible categories: not related, possibly related and probably related.

Time frame: NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)

Secondary Outcomes

Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)

Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)

Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose

Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)

Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

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)

Time frame: Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose

Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)

Data from ClinicalTrials.gov

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