A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382431
• Other study ID #: PC_RSV_003
• Secondary ID: 2017-002563-18
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 14, 2017
• Est. completion date: May 9, 2018

Study information

• Verified date: May 2018
• Source: Pulmocide Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 9, 2018
• Est. primary completion date: May 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• PC786
Repeat doses
• Placebo/vehicle
Repeat doses

Locations

Country	Name	City	State
United Kingdom	hVIVO Services Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Pulmocide Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of participants reporting one or more treatment-emergent adverse event (TEAE)		Screening to Day 28
Secondary	Number of participants who discontinue due to an adverse event		Screening to Day 28
Secondary	Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose		Screening to Day 28
Secondary	Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose		Screening to Day 28
Secondary	Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose		Screening to Day 28
Secondary	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
Secondary	Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma		Pre-dose and at multiple time points to Day 12
Secondary	Maximum observed concentration (Cmax) of PC786 measured in plasma		Pre-dose and at multiple time points to Day 12
Secondary	Time maximum concentration observed (Tmax) of PC786 measured in plasma		Pre-dose and at multiple time points to Day 12
Secondary	Apparent terminal half life (T1/2) of PC786 measured in plasma		Pre-dose and at multiple time points to Day 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in viral load measured in nasal wash	Change in viral load before first dose of PC786 to Day 12	Baseline to Day 12
Secondary	Time to non-detectability of virus measured in nasal wash		Baseline to Day 12
Secondary	Peak viral load measured in nasal wash		Baseline to Day 12
Secondary	Time peak viral load observed measured in nasal wash		Baseline to Day 12