Asthma Exacerbation, Healthy Adult Participants, Safety and Efficacy
Conditions
Brief summary
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
Interventions
DRUGRIG-101
Single, and repeat escalating intranasal administrations of RIG-101
OTHERPlacebo
Single and repeat Intranasal administrations
Sponsors
RIGImmune Inc.
Virtus Respiratory Research
Medicines Evaluation Unit Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1-35 | All adverse events (AEs) and serious adverse events (SAEs) will be collected using standard regulatory AE/SAE monitoring procedures. Events will be assessed for severity and relationship to intranasal RIG-101 according to protocol-defined criteria. Data will be recorded from the signing of informed consent through the follow-up visit. |
| Systolic/Diastolic blood pressure | Day 0 - 35 | Systolic/Diastolic blood pressure will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline mmHg |
| Physical examinations | Day 0 -35 | Physical examinations-general and system-specific (cardiovascular, respiratory, ENT, lymphatic, neurological, abdominal, musculoskeletal, dermatologic)-will be performed per protocol. Findings will be categorized as normal or abnormal, with clinical significance determined by the investigator. Unit of Measure: Incidence of clinically significant physical exam abnormalities |
| Nasal examinations | Day 0 - 35 | Nasal examinations are performed to identify structural anomalies, inflammation, or other abnormalities in the anterior nares. Unit of Measure: Incidence of nasal exam abnormalities |
| Spirometry (FEV₁ and FVC) | Day 0-35 | Spirometry (FEV₁ and FVC) will be conducted per ATS/ERS 2019 standards. Predicted values will use the GLI global dataset. Unit of Measure: Change from baseline in litres Measurement Tool: ATS/ERS-compliant spirometers |
| Triplicate 12-lead ECGs and single 12-lead ECGs | Day 0 - 35 | Triplicate 12-lead ECGs and single 12-lead ECGs will be collected after ≥5 minutes of supine rest. Parameters include HR, PR interval, QRS duration, QT, and QTcF. Unit of Measure: Change from baseline in ECG parameters |
| Safety laboratory testing-haematology | Day 0 - 35 | Safety laboratory testing-haematology, will be assessed per protocol and judged for clinical significance. Unit of Measure: Change in parameters of haematology laboratory values assessed using local lab reference ranges |
| Safety laboratory testing-Serum Chemistry | Day 0- 35 | Safety laboratory testing-Serum chemistry, will be assessed per protocol and judged for clinical significance. Unit of Measure: Change in parameters of Serum chemistry laboratory values assessed using local lab reference ranges |
| Safety laboratory testing-Coagulation | Day 0 -35 | Safety laboratory testing-Coagulation will be assessed per protocol and judged for clinical significance. Unit of Measure: Change in parameters of Coagulation laboratory values assessed using local lab reference ranges |
| Lower respiratory tract symptom score assessments | Day -7 to 35 | Participants complete twice-daily LRSS assessments for 35 days. The primary endpoint is the total symptom burden expressed as area under the curve (AUC) for LRSS from baseline through Day 35. Unit of Measure: AUC (LRSS × days) Measurement Tool: Twice-daily electronic diary (eDiary) symptom scoring system |
| AUC of Lower respiratory tract symptom score | Day -7 to 35 | AUC of LRSS where the lower respiratory symptoms are measured for 35 days by twice-daily date and time stamped eDiary collection |
| Vital Signs - heart rate | Day 0 - 35 | Heart rate will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline BPM |
Countries
United Kingdom
Outcome results
None listed