Safety,Tolerability & PK of JNJ-53718678 in Healthy Japanese Subjects

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, randomized, single ascending dose study to investigate safety, tolerability, and pharmacokinetics of JNJ 53718678 in healthy Japanese adult subjects

• IRAS ID

  173573

• Sponsor organisation

  Janssen-Cilag B.V.

• Eudract number

  2014-005410-36

• Duration of Study in the UK

  0 years, 2 months, 1 days

• Research summary

  The new medicine tested in this study is a compound called JNJ-53718678. The Sponsor is developing this study drug for treating respiratory syncytial virus (RSV), which causes lower respiratory tract infections. RSV is considered the most important virus which causes acute lower respiratory tract infection. The study drug interferes with a process that the RSV uses to survive and multiply in the body. In laboratory studies, the study drug stopped RSV from multiplying.

  The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing in Japanese adults; this is done by finding out if the study drug causes side effects (unexpected or unwanted reactions from taking a drug). The study will also investigate how long the study drug stays in and acts on the body, by looking at how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted.

  This study will recruit healthy, non-smoking, Japanese males and females (of non-childbearing potential) between the ages of 20 and 55 years. A total of approximately 24 subjects will take part in the study.

  The study duration is approximately 6 weeks, consisting of a screening visit, treatment period and follow-up visit.

  Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic analysis will be collected.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  15/LO/0235

• Date of REC Opinion

  19 Mar 2015

• REC opinion

  Further Information Favourable Opinion