A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
15. maj 2018 opdateret af: Pulmocide Ltd
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
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
London, Det Forenede Kongerige, E1 2AX
- hVIVO Services Ltd
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: PC786
Repeat dose
|
Repeat doses
|
|
Placebo komparator: Placebo/vehicle
Repeat dose
|
Repeat doses
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
RSV viral load
Tidsramme: Baseline to Day 28
|
AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
|
Baseline to Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants reporting one or more treatment-emergent adverse event (TEAE)
Tidsramme: Screening to Day 28
|
Screening to Day 28
|
|
|
Number of participants who discontinue due to an adverse event
Tidsramme: Screening to Day 28
|
Screening to Day 28
|
|
|
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Tidsramme: Screening to Day 28
|
Screening to Day 28
|
|
|
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Tidsramme: Screening to Day 28
|
Screening to Day 28
|
|
|
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Tidsramme: Screening to Day 28
|
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
Tidsramme: Screening to Day 28
|
Screening to Day 28
|
|
|
Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma
Tidsramme: Pre-dose and at multiple time points to Day 12
|
Pre-dose and at multiple time points to Day 12
|
|
|
Maximum observed concentration (Cmax) of PC786 measured in plasma
Tidsramme: Pre-dose and at multiple time points to Day 12
|
Pre-dose and at multiple time points to Day 12
|
|
|
Time maximum concentration observed (Tmax) of PC786 measured in plasma
Tidsramme: Pre-dose and at multiple time points to Day 12
|
Pre-dose and at multiple time points to Day 12
|
|
|
Apparent terminal half life (T1/2) of PC786 measured in plasma
Tidsramme: Pre-dose and at multiple time points to Day 12
|
Pre-dose and at multiple time points to Day 12
|
|
|
Determination of nasal concentrations of PC786
Tidsramme: Pre-dose and at multiple time points to Day 28
|
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
Tidsramme: Baseline to Day 12
|
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
Tidsramme: 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)
|
Baseline to Day 12
|
|
Change in viral load measured in nasal wash
Tidsramme: Baseline to Day 12
|
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
Tidsramme: Baseline to Day 12
|
Baseline to Day 12
|
|
|
Peak viral load measured in nasal wash
Tidsramme: Baseline to Day 12
|
Baseline to Day 12
|
|
|
Time peak viral load observed measured in nasal wash
Tidsramme: Baseline to Day 12
|
Baseline to Day 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Bryan J Murray, MBBS, hVIVO Services Ltd
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2017
Primær færdiggørelse (Faktiske)
9. maj 2018
Studieafslutning (Faktiske)
9. maj 2018
Datoer for studieregistrering
Først indsendt
8. december 2017
Først indsendt, der opfyldte QC-kriterier
18. december 2017
Først opslået (Faktiske)
22. december 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PC_RSV_003
- 2017-002563-18 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .