NCT02826018

A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

A Phase 1/2, Randomized, Single-Blind, Placebo-Controlled, Single-Ascending and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Antiviral Efficacy Study of Subcutaneously Administered ALN-HBV in Healthy Adult Subjects and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.

Detailed description

The study has 3 parts. Part A is a single ascending dose (SAD) study in healthy volunteers. Part B is a single ascending dose study (SAD) in patients with HBV infection. Part C is a multiple ascending dose study (MAD) in patients with HBV infection.

Conditions

• Hepatitis B
• Chronic Hepatitis B
• Hepatitis B, Chronic
• Hepatitis B Infection
• HBV

Interventions

Type	Name	Description
DRUG	ALN-HBV	Ascending doses of ALN-HBV by subcutaneous (sc) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	Calculated volume to match active comparator

Timeline

• Start date: 2016-06-24
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-07-07
• Last updated: 2018-09-24

Locations

9 sites across 6 countries: Australia, Hong Kong, New Zealand, Singapore, South Korea, United Kingdom