SAD, MAD, PK Study of SC ALN-HBV in healthy volunteers and patients
Research type
Research Study
Full title
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
IRAS ID
196107
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc
Eudract number
2015-004360-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
We are conducting a First-in-Human trial with an investigational medication known as ALN-HBV which is being developed for the treatment of chronic hepatitis-B virus infection. \nHepatitis B is an infectious disease caused by the hepatitis-B virus (HBV) which affects the liver and may lead to chronic infections. Individuals with chronic hepatitis-B may develop gradual loss of liver tissue, progressive loss of liver function and potentially cancer. Detection of HBV involves blood tests that identify the virus DNA, antibodies and antigens (proteins produced by the virus).\nCurrent treatment for chronic HBV infection such as nucleotide/nucleoside therapies (NUC therapy) may not result in a cure failing to eliminate the virus while other therapies are associated with frequent side-effects. \nThe primary objective is to assess the safety, tolerability and efficacy of ALN-HBV, measured by changes in HBV DNA and/or antigen levels. We will also measure how much ALN-HBV is found in the blood and urine after dosing (pharmacokinetics). The study will be carried out in 4 parts: a single ascending dose phase in healthy volunteers (Part A), a single ascending dose phase in patients on standard NUC therapy (Part B), a multiple ascending dose phase in patients on standard NUC therapy (Part C), and a multiple dose phase in patients with quantifiable HBV DNA in blood and who have not previously received anti-HBV therapy (Part D).\nThe time commitment required from each volunteer is 74, 130, and 221 days for parts A, B, C/D respectively.\nThe study will be conducted at Richmond Pharmacology and other sites and is funded by Alnylam Pharmaceuticals Inc., which is a biopharmaceutical company based in Cambridge MA, USA.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0009
Date of REC Opinion
8 Feb 2016
REC opinion
Further Information Favourable Opinion