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Completed

NCT Number: NCT03382431

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

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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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

hVIVO Services Ltd

London, E1 2AX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PC786

Drug

Repeat doses

Placebo/vehicle

Drug

Repeat doses

Primary outcomes

  1. RSV viral load

    Time frame: 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 outcomes

  1. Number of participants reporting one or more treatment-emergent adverse event (TEAE)

    Time frame: Screening to Day 28

  2. Number of participants who discontinue due to an adverse event

    Time frame: Screening to Day 28

  3. 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

  4. Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose

    Time frame: Screening to Day 28

  5. Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose

    Time frame: Screening to Day 28

  6. 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

  7. 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

  8. Maximum observed concentration (Cmax) of PC786 measured in plasma

    Time frame: Pre-dose and at multiple time points to Day 12

  9. Time maximum concentration observed (Tmax) of PC786 measured in plasma

    Time frame: Pre-dose and at multiple time points to Day 12

  10. Apparent terminal half life (T1/2) of PC786 measured in plasma

    Time frame: Pre-dose and at multiple time points to Day 12

  11. Determination of nasal concentrations of PC786

    Time frame: Pre-dose and at multiple time points to Day 28

    PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix

  12. Comparison of mucus production following treatment with PC786 or placebo post viral inoculation

    Time frame: Baseline to Day 12

    Reduction in weight of mucus produced post viral infection

  13. Comparison of the effect of treatment with PC786 or placebo on RSV symptoms

    Time frame: 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)

  14. Change in viral load measured in nasal wash

    Time frame: Baseline to Day 12

    Change in viral load before first dose of PC786 to Day 12

  15. Time to non-detectability of virus measured in nasal wash

    Time frame: Baseline to Day 12

  16. Peak viral load measured in nasal wash

    Time frame: Baseline to Day 12

  17. Time peak viral load observed measured in nasal wash

    Time frame: Baseline to Day 12

Sponsors and collaborators

Lead sponsor

Pulmocide Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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