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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002563-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC786 | Experimental | Repeat dose |
|
| Placebo/vehicle | Placebo Comparator | Repeat dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC786 | Drug | Repeat doses |
| |
| Placebo/vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| RSV viral load | AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR) | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting one or more treatment-emergent adverse event (TEAE) | Screening to Day 28 | |
| Number of participants who discontinue due to an adverse event | Screening to Day 28 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan J Murray, MBBS | hVIVO Services Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hVIVO Services Ltd | London | E1 2AX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33216113 | Derived | DeVincenzo J, Cass L, Murray A, Woodward K, Meals E, Coates M, Daly L, Wheeler V, Mori J, Brindley C, Davis A, McCurdy M, Ito K, Murray B, Strong P, Rapeport G. Safety and Antiviral Effects of Nebulized PC786 in a Respiratory Syncytial Virus Challenge Study. J Infect Dis. 2022 Jun 15;225(12):2087-2096. doi: 10.1093/infdis/jiaa716. |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000626983 | PC-786 |
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| Drug |
Repeat doses |
|
| 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 |
| Apparent terminal half life (T1/2) of PC786 measured in plasma | Pre-dose and at multiple time points to Day 12 |
| Determination of nasal concentrations of PC786 | PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix | Pre-dose and at multiple time points to Day 28 |
| Comparison of mucus production following treatment with PC786 or placebo post viral inoculation | Reduction in weight of mucus produced post viral infection | Baseline to Day 12 |
| Comparison of the effect of treatment with PC786 or placebo on RSV symptoms | 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) | Baseline to Day 12 |
| Change in viral load measured in nasal wash | Change in viral load before first dose of PC786 to Day 12 | Baseline 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 |
| D014777 | Virus Diseases |
| D007239 | Infections |