Respiratory Syncytial Virus InfectionsPhase 1/2NCT03382431
A Study of PC786 to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of Multiple Doses in an RSV Challenge Study
A Phase 1/2 study testing PC786 in people with Respiratory Syncytial Virus Infections, run by Pulmocide Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- PC786
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2017to 9 May 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- PC786, Placebo/vehicle
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC786Drug
Repeat doses
Placebo/vehicleDrug
Repeat doses
| Study group | Role | What they receive |
|---|---|---|
| PC786 | Experimental | Repeat dose Receives: Drug: PC786 |
| Placebo/vehicle | Placebo comparator | Repeat dose Receives: Drug: Placebo/vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV viral load
AUC 0-t for RSV viral load measured in nasal washes by reverse transcription quantitative polymerase chain reaction (RT-qPCR)
Measured: Baseline to Day 28
Secondary outcomes (17)
Number of participants reporting one or more treatment-emergent adverse event (TEAE)
Measured: Screening to Day 28
Number of participants who discontinue due to an adverse event
Measured: Screening to Day 28
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Measured: Screening to Day 28
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Measured: Screening to Day 28
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Measured: 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
Measured: Screening to Day 28
Area under the plasma concentration versus time curve (AUC) of PC786 measured in plasma
Measured: Pre-dose and at multiple time points to Day 12
Maximum observed concentration (Cmax) of PC786 measured in plasma
Measured: Pre-dose and at multiple time points to Day 12
Time maximum concentration observed (Tmax) of PC786 measured in plasma
Measured: Pre-dose and at multiple time points to Day 12
Apparent terminal half life (T1/2) of PC786 measured in plasma
Measured: Pre-dose and at multiple time points to Day 12
Determination of nasal concentrations of PC786
PC786 concentrations in mucosal lining fluid collected using synthetic absorptive matrix
Measured: Pre-dose and at multiple time points to Day 28
Comparison of mucus production following treatment with PC786 or placebo post viral inoculation
Reduction in weight of mucus produced post viral infection
Measured: Baseline to Day 12
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)
Measured: Baseline to Day 12
Change in viral load measured in nasal wash
Change in viral load before first dose of PC786 to Day 12
Measured: Baseline to Day 12
Time to non-detectability of virus measured in nasal wash
Measured: Baseline to Day 12
Peak viral load measured in nasal wash
Measured: Baseline to Day 12
Time peak viral load observed measured in nasal wash
Measured: Baseline to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start14 Nov 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan J Murray, MBBS, Principal investigator, hVIVO Services Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382431
- Sponsor's protocol ID
- PC_RSV_003
- Other IDs
- 2017-002563-18, 2017
- Status last verified
- May 2018
- First submitted
- 8 Dec 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33216113
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03382431
- Acronym / sponsor ID
- PC_RSV_003
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pulmocide LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC786 | Experimental | Drug: PC786Repeat dose |
| Placebo/vehicle | Placebo comparator | Drug: Placebo/vehicleRepeat dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC786Repeat doses | Drug | PC786 |
| Placebo/vehicleRepeat doses | Drug | Placebo/vehicle |
Primary outcome
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)
17 secondary outcomes
Number of participants reporting one or more treatment-emergent adverse event (TEAE)
Time frame: Screening to Day 28
Number of participants who discontinue due to an adverse event
Time frame: Screening to Day 28
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
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Time frame: Screening to Day 28
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Time frame: 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
Time frame: Screening to Day 28
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
Maximum observed concentration (Cmax) of PC786 measured in plasma
Time frame: Pre-dose and at multiple time points to Day 12
Time maximum concentration observed (Tmax) of PC786 measured in plasma
Time frame: Pre-dose and at multiple time points to Day 12
Apparent terminal half life (T1/2) of PC786 measured in plasma
Time frame: Pre-dose and at multiple time points to Day 12
Determination of nasal concentrations of PC786
Time frame: Pre-dose and at multiple time points to Day 28
Comparison of mucus production following treatment with PC786 or placebo post viral inoculation
Time frame: Baseline to Day 12
Comparison of the effect of treatment with PC786 or placebo on RSV symptoms
Time frame: Baseline to Day 12
Change in viral load measured in nasal wash
Time frame: Baseline to Day 12
Time to non-detectability of virus measured in nasal wash
Time frame: Baseline to Day 12
Peak viral load measured in nasal wash
Time frame: Baseline to Day 12
Time peak viral load observed measured in nasal wash
Time frame: Baseline to Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 33216113DeVincenzo 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.
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan J Murray, MBBS principal investigator
hVIVO Services Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PC786 in people with Respiratory Syncytial Virus Infections, run by Pulmocide Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV viral load (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.