JNJ-64417184 – first doses in humans; v2 (17-015)
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, First-in-human, 6 Part Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Subjects. HMR code (17-015)
IRAS ID
238666
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Janssen Pharmaceutica NV
Eudract number
2017-004363-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine, JNJ-64417184, is an experimental new medicine for infections caused by a virus called Respiratory Syncytial Virus (RSV). In some people, like babies and the elderly, RSV can cause a serious illness, such as pneumonia. JNJ-64417184 works differently than existing treatments, by blocking a substance that the virus uses to multiply itself. \n\nThis is a 4-part study in healthy volunteers, aged 18-55.\n\nIn Part 1, we’ll give up to 8 groups of 8 participants single doses of the study medicine. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels. \n\nParticipants in Group 3 of Part 1 will also do Part 2 (single doses after a fatty breakfast) at least 10 days after Part 1. We’ll test whether food affects the blood levels of the study medicine.\n\nIn Part 3, we’ll test repeated doses of the study medicine, in up to 6 groups of 10 participants, to find out its side effects and blood levels. We’ll increase the dose as the study progresses.\n\nIn Part 4, we’ll test repeated doses of the study medicine in up to 44 participants, after exposing them to a common strain of RSV (RSV-A Memphis 37b). We’ll assess side effects, blood levels, and if the study medicine protects participants from RSV.\n\nParticipants will take up to 12 weeks to finish the study, depending on the study part. They’ll stay on the ward for:\n\n*4 nights in Part 1 \n*8 nights in Part 2\n*10 nights in Part 3\n*14 nights in Part 4\n\nThey’ll also make 3–8 outpatient visits.\n\nA pharmaceutical company (Alios BioPharma) is funding the study.\n\nThe study will take place at 2 centres in London.\n
REC name
HSC REC A
REC reference
17/NI/0239
Date of REC Opinion
5 Feb 2018
REC opinion
Further Information Favourable Opinion