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

Hepatitis B Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03365947
• Other study ID #: AROHBV1001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 27, 2018
• Est. completion date: April 23, 2020

Study information

• Verified date: April 2021
• Source: Arrowhead Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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

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

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St. Vincent's Hospital	Melbourne	Victoria
Australia	Linear Research	Nedlands	Western Australia
Hong Kong	Queen Mary Hospital	Hong Kong
New Zealand	Auckland Clinical Studies Limited	Grafton	Auckland
New Zealand	Middlemore Clinical Trials	Papatoetoe	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Hong Kong,  New Zealand, 

Outcome

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