Respiratory Syncytial Virus Infections
Conditions
Brief summary
PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults infected with RSV virus in a viral challenge study.
Interventions
DRUGPC786
Repeat doses
DRUGPlacebo/vehicle
Repeat doses
Sponsors
Pulmocide Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is in good health as determined by the Investigator based on medical history, physical examination, and routine laboratory tests at a screening evaluation. * Male or female, aged between 18 and 55 years inclusive * Body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 30kg/m2 * Subject must provide written informed consent * Serosuitable to the challenge virus.
Exclusion criteria
* History or evidence of any clinically significant or currently active major clinical illness. * Any significant abnormality altering the anatomy of the nose or nasopharynx * Any nasal or sinus surgery within six months of the study * Abnormal lung function * Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test. * Presence of cold like symptoms and/or fever on admission for the study * History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks of the study * History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV viral load | Baseline to Day 28 | AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinue due to an adverse event | Screening to Day 28 | — |
| Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose | Screening to Day 28 | — |
| Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose | Screening to Day 28 | — |
| Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose | Screening to Day 28 | — |
| Number of participants who meet the markedly abnormal criteria for spirometry (FEV1 & FVC measured together) assessments at least once post dose | Screening to Day 28 | — |
| Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma | Pre-dose and at multiple time points to Day 12 | — |
| Maximum observed concentration (Cmax) of PC786 measured in plasma | Pre-dose and at multiple time points to Day 12 | — |
| Time maximum concentration observed (Tmax) of PC786 measured in plasma | Pre-dose and at multiple time points to Day 12 | — |
| Number of participants reporting one or more treatment-emergent adverse event (TEAE) | Screening to Day 28 | — |
| Determination of nasal concentrations of PC786 | Pre-dose and at multiple time points to Day 28 | PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix |
| Comparison of mucus production following treatment with PC786 or placebo post viral inoculation | Baseline to Day 12 | Reduction in weight of mucus produced post viral infection |
| Comparison of the effect of treatment with PC786 or placebo on RSV symptoms | Baseline to Day 12 | Composite score of self-reported symptoms on a symptom diary card. Nasal symptoms, sneezing, sore throat, cough, headache, wheezing, chest tightness, shortness of breath, joint aches, feverishness, malaise, earache are assessed using a score of 0 (no symptoms), 1 (just noticeable), 2 (bothersome but able to participate in activities), 3 (bothersome and not able to participate in activities) |
| Change in viral load measured in nasal wash | Baseline to Day 12 | Change in viral load before first dose of PC786 to Day 12 |
| Time to non-detectability of virus measured in nasal wash | Baseline to Day 12 | — |
| Peak viral load measured in nasal wash | Baseline to Day 12 | — |
| Time peak viral load observed measured in nasal wash | Baseline to Day 12 | — |
| Apparent terminal half life (T1/2) of PC786 measured in plasma | Pre-dose and at multiple time points to Day 12 | — |
Countries
United Kingdom
Outcome results
None listed