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

September 20, 2018 updated by: Alnylam Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • Clinical Trial Site
    • Victoria
      • Fitzroy, Victoria, Australia
        • Clinical Trial Site
      • Parkville, Victoria, Australia
        • Clinical Trial Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Clinical Trial Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Clinical Trial Site
      • Seoul, Korea, Republic of, 05505
        • Clinical Trial Site
  • New Zealand
      • Auckland, New Zealand
        • Clinical Trial Site
  • Singapore
      • Singapore, Singapore
        • Clinical Trial Site
  • United Kingdom
      • London, United Kingdom
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All subjects:

  • 18 to 65 years inclusive
  • Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception
  • Agrees not to donate blood during the duration of the study
  • Willing to comply with the study requirements and to provide written informed consent

Additional inclusion criteria for patients with HBV infection:

  • Body mass index (BMI) ≥18.0 kg/m2
  • Must be on a stable regimen of entecavir or tenofovir

Exclusion Criteria:

All subjects:

  • Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk
  • Subjects with a history of serious mental illness
  • Active infection with human immunodeficiency virus (HIV) infection, hepatitis A virus (HAV), or hepatitis C virus (HCV) infection and/or a history of delta virus hepatitis
  • Known hypersensitivity or contraindication to any medication or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)

Additional exclusion criteria for healthy volunteers:

  • Evidence of liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sterile Normal Saline (0.9% NaCl)
Drug: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Active Comparator: ALN-HBV
Drug: ALN-HBV
Ascending doses of ALN-HBV by subcutaneous (sc) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing adverse events
Time Frame: Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176
Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Pharmacokinetics (PK) of ALN-HBV
Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Maximum plasma concentration (Cmax)
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Profile of Pharmacokinetics (PK) of ALN-HBV
Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Elimination half-life (t1/2)
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Profile of Pharmacokinetics (PK) of ALN-HBV
Time Frame: Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Area under the concentration-time curve (AUC)
Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85
Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels
Time Frame: Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176
Change in HBsAg levels from baseline
Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

  • Study Director: Stephen Huang, MD, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 24, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-HBV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Sterile Normal Saline (0.9% NaCl)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe