HRV16 challenge study to examine JNJ-43260295 in healthy subjects

• Research type

  Research Study

• Full title

  A phase Ib, single dose, partially double-blind, randomised, and controlled HRV 16 (RVL) human viral challenge study to examine the efficacy, cytokine response, safety and tolerability of JNJ-43260295 in healthy subjects.

• IRAS ID

  119341

• Contact name

  Bryan Murray

• Sponsor organisation

  Janssen R&D Ireland

• Eudract number

  2012-005579-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The common cold encompasses a range of viral infections of the upper respiratory tract (sinuses, nose, throat and main airway) and is the most common infectious disease of humans. Human rhinovirus (HRV) infection is associated with up to 80% of ??colds?? in the peak season. In the general population a ??cold?? is self-limiting but the frequency of attacks can have a large impact on both a person??s social and work life. There is a demand for the development of effective therapies to treat or prevent rhinovirus infection, which could help reduce the serious health effects in vulnerable populations. The Sponsor has developed the study drug, an immunomodulator which adjusting the body??s own in-built defensive system, the immune system, the cells and mechanisms by which your body defends itself against infections. It may therefore be useful in providing protection against common cold viruses, especially rhinoviruses, in those at risk of complications from a rhinovirus infection. This is a Phase 1b, so ??proof of concept?? study, to look at the efficacy, safety, tolerability and body??s immune response to a single nasal dose of study drug after being infected with a common strain of human rhinovirus, HRV16(RVL). The study consists of 3 parts: Screening, the Quarantine Phase and Follow Up. Screening will take place up to 45 days before quarantine where volunteers will be asked to complete an informed consent and undergo scheduled screening assessments to determine their eligibility. If volunteers fulfil all eligibility criteria they will be invited to attend the Quarantine Phase on Day -2 (2 days before inoculation) in Group 1, and Day -8 and / or Day -2 in Groups 2 and 3. The Quarantine (Challenge) Phase is where the volunteers will be admitted to the purpose built quarantine facility in London to be given the study drug. The subjects will be inoculation with HRV16 on day 0 and dosed with the study drug in quarantine 1 on day -1 and Quarantine 2 and 3 on days -1 and/or -7. Up to 3 groups of 22 subjects will be included. The 2nd and 3rd groups are optional depending on safety data review between groups. Within each group volunteers will be randomised to either: 9 double-blinded volunteers to receive the study drug, 9 double-blind to receive a starch vehicle (placebo) and 4 non-blinded volunteers receiving no treatment to indicate the HRV infection rate for each group. The dose of study drug will be the maximum tolerated and safest dose as determined by the ongoing study, 43260295HRV1001. Volunteers will remain in the quarantine unit for 8 days after inoculation but should medical monitoring warrant an additional night or 2 stay then they may be asked to stay longer. During the day 28 ( 5) end of study visit, each volunteer will be seen and assessed by a study physician for well-being, ongoing symptoms and adverse events.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/0009

• Date of REC Opinion

  20 Jan 2013

• REC opinion

  Favourable Opinion