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: May 2024
• 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

• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Drug:
• ARO-HBV
sc injection

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

Drug:
• JNJ-56136379
oral tablets

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, 

References & Publications (1)

Yuen MF, Locarnini S, Lim TH, Strasser SI, Sievert W, Cheng W, Thompson AJ, Given BD, Schluep T, Hamilton J, Biermer M, Kalmeijer R, Beumont M, Lenz O, De Ridder F, Cloherty G, Ka-Ho Wong D, Schwabe C, Jackson K, Lai CL, Gish RG, Gane E. Combination treat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	NHV participants: up to Day 29 (± 2 days); CHB participants: Day 113 (± 2 days)
Secondary	Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	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)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½)		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax		Day 1: 0 (pre-dose), 15 minutes, 0.5, 1, 2, 3, 6, 24 & 48 hours post-dose
Secondary	Change From Baseline in 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