Back to resultsA Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
PC786
Placebo/vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections
Eligibility Criteria
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
Sites / Locations
- hVIVO Services Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PC786
Placebo/vehicle
Arm Description
Repeat dose
Repeat dose
Outcomes
Primary Outcome Measures
RSV viral load
AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
Secondary Outcome Measures
Number of participants reporting one or more treatment-emergent adverse event (TEAE)
Number of participants who discontinue due to an adverse event
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Number of participants who meet the markedly abnormal criteria for spirometry (FEV1 & FVC measured together) assessments at least once post dose
Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma
Maximum observed concentration (Cmax) of PC786 measured in plasma
Time maximum concentration observed (Tmax) of PC786 measured in plasma
Apparent terminal half life (T1/2) of PC786 measured in plasma
Determination of nasal concentrations of PC786
PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix
Comparison of mucus production following treatment with PC786 or placebo post viral inoculation
Reduction in weight of mucus produced post viral infection
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)
Change in viral load measured in nasal wash
Change in viral load before first dose of PC786 to Day 12
Time to non-detectability of virus measured in nasal wash
Peak viral load measured in nasal wash
Time peak viral load observed measured in nasal wash
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03382431
Brief Title
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
Official Title
A Single-blind, Placebo Controlled, Randomised Study to Evaluate Antiviral Activity and Safety and Pharmacokinetics of Inhaled PC786 Against Respiratory Syncytial Virus (RSV) in Healthy Adult Subjects in a Virus Challenge Model
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmocide Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PC786
Arm Type
Experimental
Arm Description
Repeat dose
Arm Title
Placebo/vehicle
Arm Type
Placebo Comparator
Arm Description
Repeat dose
Intervention Type
Drug
Intervention Name(s)
PC786
Intervention Description
Repeat doses
Intervention Type
Drug
Intervention Name(s)
Placebo/vehicle
Intervention Description
Repeat doses
Primary Outcome Measure Information:
Title
RSV viral load
Description
AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Number of participants reporting one or more treatment-emergent adverse event (TEAE)
Time Frame
Screening to Day 28
Title
Number of participants who discontinue due to an adverse event
Time Frame
Screening to Day 28
Title
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Time Frame
Screening to Day 28
Title
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Time Frame
Screening to Day 28
Title
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Time Frame
Screening to Day 28
Title
Number of participants who meet the markedly abnormal criteria for spirometry (FEV1 & FVC measured together) assessments at least once post dose
Time Frame
Screening to Day 28
Title
Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma
Time Frame
Pre-dose and at multiple time points to Day 12
Title
Maximum observed concentration (Cmax) of PC786 measured in plasma
Time Frame
Pre-dose and at multiple time points to Day 12
Title
Time maximum concentration observed (Tmax) of PC786 measured in plasma
Time Frame
Pre-dose and at multiple time points to Day 12
Title
Apparent terminal half life (T1/2) of PC786 measured in plasma
Time Frame
Pre-dose and at multiple time points to Day 12
Title
Determination of nasal concentrations of PC786
Description
PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix
Time Frame
Pre-dose and at multiple time points to Day 28
Title
Comparison of mucus production following treatment with PC786 or placebo post viral inoculation
Description
Reduction in weight of mucus produced post viral infection
Time Frame
Baseline to Day 12
Title
Comparison of the effect of treatment with PC786 or placebo on RSV symptoms
Description
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)
Time Frame
Baseline to Day 12
Title
Change in viral load measured in nasal wash
Description
Change in viral load before first dose of PC786 to Day 12
Time Frame
Baseline to Day 12
Title
Time to non-detectability of virus measured in nasal wash
Time Frame
Baseline to Day 12
Title
Peak viral load measured in nasal wash
Time Frame
Baseline to Day 12
Title
Time peak viral load observed measured in nasal wash
Time Frame
Baseline to Day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan J Murray, MBBS
Organizational Affiliation
hVIVO Services Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
hVIVO Services Ltd
City
London
ZIP/Postal Code
E1 2AX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33216113
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
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