A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged with Human Rhinovirus (HRV-16 [hVIVO])

INTERVENTION: Product Name: PrEP‐001 (JNJ‐43260295‐AAM) Pharmaceutical Form: Nasal powder INN or Proposed INN: NA CAS Number: 42424‐50‐0 Current Sponsor code: JNJ‐43260295‐AAM Other descriptive name: JNJ‐43260295, Product Number WO643, Poly IC, Poly I: Poly C Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 800‐ Pharmaceutical form of the placebo: Nasal powder Route of administration of the placebo: Nasal use CONDITION: Human Rhinovirus (HRV‐16) ; MedDRA version: 18.0 Level: PT Classification code 10075163 Term: Human rhinovirus test System Organ Class: 10022891 ‐ Investigations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess the prophylactic effect of repeated intranasal dosing with PrEP‐001 in asthmatic subjects subsequently challenged with HRV‐16 on the changes in clinical symptoms when compared to placebo Primary end point(s): AUC of total symptom score post Viral Challenge Secondary Objective: Efficacy:; ; To determine the prophylactic effect of PrEP‐001 after repeated intranasal dosing in asthmatic subjects subsequently challenged with HRV‐16 on clinical signs and symptoms of HRV infection, rates of clinical illness, and viral shedding.; ; Safety:; ; To determine the safety and tolerability of PrEP‐001 after repeated intranasal dosing in asthmatic subjects subsequently challenged with HRV‐16. Timepoint(s) of evaluation of this end point: Up to Day 28 (+/‐ 5 Days) SECONDARY OUTCOME: Secondary end point(s): Efficacy endpoints: ; ; Symptom scores ; ‐AUC of symptom score (URT, LRT and SRT) post Viral Challenge ; ‐duration of symptoms ; ‐peak symptom score ; ‐ time to peak symptom ; ‐ time to resolution from peak symptoms ; ; Incidence(s) of illness and infection: ; ‐viral shedding ; ‐incidence of laboratory‐confirmed HRV illness based on the incidence of HRV‐like‐illness and laboratory‐confirmed infection ; ‐laboratory confirmed HRV‐16 infection ; ‐HRV‐like‐illness ; ‐sub‐clinical infection ; ‐upper respiratory tract illness ; ‐lower respiratory tract illness ; ‐febrile illness ; ‐systemic illness ; ‐non‐sick and uninfected ; ‐viral replication ; ‐seroconversion (as calculated by a ratio of HRV‐16 antibodies at follow‐up versus pre‐dose). ; ; Viral load parameters (using TCID50 and/or RT‐PCR) ; ‐ area under the curve (AUC) of viral load ; ‐duration of virus shedding ; ‐peak virus shedding ; ‐time to peak viral shedding ; ‐time to resolution from peak viral shedding. ; ; Total weight of mucus produced. ; Change in lung function (including PEF) compared with pre‐Challenge. ; ; Safety: ; ; Incidence of treatment‐emergent adverse events (AEs), severity, seriousness and causality. ; Absolute values and change from baseline in routine clinical laboratory parameters by timepoint. ; Absolute values and change from baseline in vital signs parameters by timepoint. ; Physical examination findings. ; Absolute values and change from baseline in spirometry parameters by timepoint (analysed descriptively). ; 12‐lead electrocardiogram (ECG). ; Concomitant medications. ; Number of asthma exacerbations post Viral Challenge. Timepoint(s) of evaluation of this end point: Up to Day 28 (+/‐ 5 Days) INCLUSION CRITERIA: Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP). Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3. A pre‐bronchodilator FEV1 = 60% of predicted subject’s normal value at the first screening, on admission to quarantine, and prior to dosing on Day ‐2. In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication. A total body weight = 50 kg and Body Mass Index (BMI) = 18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less th