NCT03382431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

December 8, 2017

Last Update Submit

May 15, 2018

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

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

    Screening to Day 28

  • Number of participants who discontinue due to an adverse event

    Screening to Day 28

  • Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose

    Screening to Day 28

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

    Screening to Day 28

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

    Screening to Day 28

  • +12 more secondary outcomes

Study Arms (2)

PC786

EXPERIMENTAL

Repeat dose

Drug: PC786

Placebo/vehicle

PLACEBO COMPARATOR

Repeat dose

Drug: Placebo/vehicle

Interventions

PC786DRUG

Repeat doses

PC786
Placebo/vehicleDRUG

Repeat doses

Placebo/vehicle

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hVIVO Services Ltd

London, E1 2AX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33216113DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

PC-786

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Bryan J Murray, MBBS

    hVIVO Services Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 22, 2017

Study Start

November 14, 2017

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations

GB(1)