Clinical trial NCT03382431: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Pulmocide Ltd
Sponsor class: INDUSTRY
First posted: 2017-12-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: RSV viral load
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Number of participants reporting one or more treatment-emergent adverse event (TEAE)
timeFrame: Screening to Day 28
measure: Number of participants who discontinue due to an adverse event
timeFrame: Screening to Day 28
measure: Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
timeFrame: Screening to Day 28
measure: Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
timeFrame: Screening to Day 28
measure: Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
timeFrame: Screening to Day 28
measure: Number of participants who meet the markedly abnormal criteria for spirometry (FEV1 & FVC measured together) assessments at least once post dose
timeFrame: Screening to Day 28
measure: Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma
timeFrame: Pre-dose and at multiple time points to Day 12
measure: Maximum observed concentration (Cmax) of PC786 measured in plasma
timeFrame: Pre-dose and at multiple time points to Day 12
measure: Time maximum concentration observed (Tmax) of PC786 measured in plasma
timeFrame: Pre-dose and at multiple time points to Day 12
measure: Apparent terminal half life (T1/2) of PC786 measured in plasma
timeFrame: Pre-dose and at multiple time points to Day 12
measure: Determination of nasal concentrations of PC786
timeFrame: Pre-dose and at multiple time points to Day 28
measure: Comparison of mucus production following treatment with PC786 or placebo post viral inoculation
timeFrame: Baseline to Day 12
measure: Comparison of the effect of treatment with PC786 or placebo on RSV symptoms
timeFrame: Baseline to Day 12
measure: Change in viral load measured in nasal wash
timeFrame: Baseline to Day 12
measure: Time to non-detectability of virus measured in nasal wash
timeFrame: Baseline to Day 12
measure: Peak viral load measured in nasal wash
timeFrame: Baseline to Day 12
measure: Time peak viral load observed measured in nasal wash
timeFrame: Baseline to Day 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: hVIVO Services Ltd
Study officials:
affiliation: hVIVO Services Ltd
name: Bryan J Murray, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.