A Two-part Randomized, Double-blind Placebo Controlled Trial to Assess the Safety and Tolerability of Single and Repeat Ascending Intranasal Doses of RIG-101 in Healthy Participants Followed by Repeat Daily Administration in Adult Participants With Asthma [Part A] Followed by a Randomized Double-blind Placebo Controlled Part to Assess the Efficacy and Safety of RIG-101 in Adult Participants With Asthma Before and After Viral Challenge With Human Rhinovirus RV-A16 [Part B].
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
⁃ Participants must meet all the following inclusion criteria to be eligible to participate in the trial.
• Participants must have a written informed consent obtained prior to any trial related procedure
• Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.
• Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
⁃ Additional Inclusion Criteria for Healthy Participants
⁃ \- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 / FVC ratio of \>70% absolute at screening.
⁃ Additional Inclusion Criteria for Participants with Asthma
• Participants must have a clinical diagnosis of asthma.
• Participants must have either a positive skin prick test with a wheal diameter of ≥3mm greater than control test at 15 minutes, and/or a blood eosinophil count of \> 200 cells / µL and/or a FeNO level of \> 25 ppb at screening.
• Participants must have a pre-bronchodilator FEV1 ≥65% predicted at screening
• Participants must be using SABA alone or inhaled corticosteroids (ICS) with SABA or ICS with formoterol as reliever therapy, AND/OR regular use of low to mid-dose ICS with or without LABA at a stable dose for at least 3 months prior to randomization to control their asthma.
⁃ Part B only
• Participants must have an ACQ-6 score of \> 0.75 at screening.
• Participants must have a history of asthma worsening in the previous 2 years, in response to a cold or respiratory infection, as confirmed by the participant.
• Participants must demonstrate seronegativity to RV-A16