Chronic Hepatitis B, HBV, Hepatitis B, Hepatitis B, Chronic, Hepatitis B Infection
Conditions
Keywords
RNAi therapeutic, Hepatitis B, Chronic Hepatitis B, Hepatitis B, Chronic, Hepatitis B Infection, HBV
Brief 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.
Interventions
DRUGALN-HBV
Ascending doses of ALN-HBV by subcutaneous (sc) injection
DRUGSterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing adverse events | Part A (SAD phase): through Day 29; Part B (SAD phase): through Day 85; Part C (MAD phase): through Day 176 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics (PK) of ALN-HBV | Part A (SAD phase): Day 1; Part B (SAD phase): Day 1; Part C (MAD phase): Days 1 and 85 | Maximum plasma concentration (Cmax) |
| Change from baseline in quantitative hepatitis B surface antigen (HBsAg) levels | Part B (SAD phase): baseline through Day 85; Part C (MAD phase): baseline through Day 176 | Change in HBsAg levels from baseline |
Countries
Australia, Hong Kong, New Zealand, Singapore, South Korea, United Kingdom
Outcome results
None listed