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

Alnylam Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Hepatitis B, Chronic; Chronic Hepatitis B; Hepatitis B Infection; Hepatitis B; HBV

Treatments: Drug: Sterile Normal Saline (0.9% NaCl); Drug: ALN-HBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02826018

ALN-HBV-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

ALN-HBV

Active Comparator group

Treatment:

Drug: ALN-HBV

Sterile Normal Saline (0.9% NaCl)

Placebo Comparator group

Treatment:

Drug: Sterile Normal Saline (0.9% NaCl)