Double-blind, Single Dose study of JNJ-73763989 in Japanese Volunteers
Research type
Research Study
Full title
A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
IRAS ID
264295
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
Janssen Sciences Ireland Unlimited Company
Eudract number
2019-000629-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
This is a double-blinded, placebo-controlled, randomised, parallel, single dose study to determine the Pharmacokinetics (how the drug is absorbed, distributed, metabolised and eliminated), Safety and tolerability of JNJ-73763989 in healthy Japanese Adult Participants.
The study drug (JNJ-3989) is being developed by the sponsor for antiviral treatment of the hepatitis B virus (HBV), which manifests as a chronic infection affecting the liver. JNJ-3989 is an watery clear, colourless to yellow solution that will be administered via subcutaneous (under the skin) injection. The study drug is comprised of two molecules that specifically target and control the part of the virus’ cell responsible for determining which strain it will develop into, much like DNA does in humans. This results in reduced levels of HBV proteins which would otherwise be used to produce the viral DNA and ultimately toxic proteins which induce an immune response. This has been previously associated with better management of HBV with an absence of virus in blood, loss of inflammation of liver and a long-term reduction in the risk of progressions from Chronic HBV infection to serious illnesses such as cirrhosis (scarring of the liver tissue), liver failure and hepatocellular carcinoma (malignant tumours in the liver).
This is the first study to dose JNJ-3989 in Japanese participants, however the study is not a first in human study and has been well tolerated by both healthy volunteers and HBV patients. Participants will be randomly assigned to one of the three panels; panels A, B, or C. 24 healthy Japanese adult participants will receive a single subcutaneous injection in the abdomen, the dose administrated will be 25mg for Panel A, 100mg for Panel B and 200mg for Panel C. The study will be placebo controlled whereby subjects will be randomised to either JNJ-3989 or a matching placebo in a 6:2 ratio. The study design comprises of a screening period, in house stay from Day -1 to Day 3, and two following visits; Day 15 and Day 29.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0851
Date of REC Opinion
30 May 2019
REC opinion
Favourable Opinion