Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Virtus Respiratory Research Ltd
London, United Kingdom
NOT_YET_RECRUITINGMedicines Evaluation Unit
Manchester, United Kingdom
RECRUITINGAdverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Day 1-35
Systolic/Diastolic blood pressure
Systolic/Diastolic blood pressure will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline mmHg
Time frame: Day 0 - 35
Physical examinations
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
Time frame: Day 0 -35
Nasal examinations
Nasal examinations are performed to identify structural anomalies, inflammation, or other abnormalities in the anterior nares. Unit of Measure: Incidence of nasal exam abnormalities
Time frame: Day 0 - 35
Spirometry (FEV₁ and FVC)
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
Time frame: Day 0-35
Triplicate 12-lead ECGs and single 12-lead ECGs
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
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Time frame: Day 0 - 35
Safety laboratory testing-haematology
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
Time frame: Day 0 - 35
Safety laboratory testing-Serum Chemistry
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
Time frame: Day 0- 35
Safety laboratory testing-Coagulation
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
Time frame: Day 0 -35
Lower respiratory tract symptom score assessments
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
Time frame: Day -7 to 35
AUC of Lower respiratory tract symptom score
AUC of LRSS where the lower respiratory symptoms are measured for 35 days by twice-daily date and time stamped eDiary collection
Time frame: Day -7 to 35
Vital Signs - heart rate
Heart rate will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline BPM
Time frame: Day 0 - 35