RO7239958 in Healthy Volunteers and Patients with HBV
Research type
Research Study
Full title
A RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED STUDY, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7239958 IN HEALTHY VOLUNTEERS AND PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION
IRAS ID
262519
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2018-003530-32
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
RO7239958 fights the hepatitis B virus by blocking two proteins called PAPD5 and PAPD7 (so called poly[A] polymerases) that help the virus to multiply inside liver cells. This is the first time that RO7239958 will be given to patients with hepatitis B. RO7239958 has already been tested in participants without hepatitis B who were healthy and volunteered to be the first to take the drug in Part 1 of the study.
Part 2 follows from Part 1 and will study RO7239958 in patients with hepatitis B. The purpose of Part 2 is to find out whether RO7239958 is safe and well tolerated, how it is absorbed and cleared from the body (so called pharmacokinetics; PK) and what effects it has on the hepatitis B virus (so called pharmacodynamics; PD). The pateint will be carefully monitored and blood and urine samples will be taken at regular intervals during the study to help understand the safety, PK and PD effects of RO7239958.
This study consists of two parts. Parts 1 in which the UK will not be participating in. Part 2 consists of two sub-parts, Part 2a and Part 2b. In both sub-parts, patients with hepatitis B will take RO7239958 or placebo.
In Part 2a, patients will receive RO7239958 or placebo for a total of 4 weeks. Patients may enter one of 5 different treatment groups (so called Arms). Each arm will include seven participants, six receiving RO7239958 and one receiving placebo. Initially participants will be enrolled in one of three arms (Arms 1 to 3), which will run in parallel to study different doses of RO7239958 given once weekly or once every two weeks. Study drug can be administered once weekly (5 administration) , once every other week (3 administration) or once monthly (2 administration) depending on what arm they are assigned. The study drug is an injection administered subcutaneously (under the skin).
Two additional arms (Arms 4 and 5) will open after Arms 1 to 3 have studied a sufficient number of participants to provide safety, tolerability, PK and PD information required to further inform the dose and frequency of administration. Arms 4 and 5 are expected to run in parallel and RO7239958 or placebo may be taken weekly or less frequently, for example every two weeks or every four weeks. This will be decided before Arms 4 and 5 start based on the data from Arms 1 to 3. Safety will be observed in a sufficient number of participants of Arms 1-3 for a minimum of 28 days before starting Arms 4 and 5.
Part 2b is an optional part of the study and may or not be run depending on the need to study RO7239958 in more detail. It will have two arms (Arms 6 and 7), each including seven participants (six receiving RO7239958 and one receiving placebo).
In Part 2a or Part 2b of the study, once the period of treatment is completed, we will ask the patient to return for safety and follow-up visits for 12 weeks. During this period we will continue to monitor safety and PD markers.
Over all approximately 35-49 participants will take part in Part 2 of study, the patient can participate in one Part and one Arm only.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0726
Date of REC Opinion
14 Jun 2019
REC opinion
Further Information Favourable Opinion