Respiratory Syncytial Virus (RSV)Phase 1NCT03236233
A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786
A Phase 1 study testing PC786 - Single doses and PC786 - Repeat doses in people with Respiratory Syncytial Virus (RSV), run by Pulmocide Ltd at 1 site in United Kingdom.
Trial summary
This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- PC786 - Single doses and PC786 - Repeat doses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jun 2017to 15 Dec 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects (Cohorts 1, 2, 3 \& 4)
- Must be male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: women of childbearing potential who are willing and able to use contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
- Females must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urinary pregnancy test at Day -1.
- Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 - 30 kg/m2 (inclusive).
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- Average QTcF <450 msec at screening and pre-dose.
- Vital signs assessments within normal ranges at screening and pre-dose.
- Healthy Subjects (Cohorts 1, 2 \& 3)
- Healthy as determined by a physician based on a full medical examination including medical history, physical examination and laboratory tests performed at screening and pre-dose.
- Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio > 0.7 at screening
- Subjects with Asthma (Cohort 4)
- Documented diagnosis of asthma, first diagnosed at least 12 months prior to the screening visit.
- Subject must demonstrate a PC20 methacholine ≤ 8 mg/mL at the screening visit.
- Have an FEV1 >60% of predicted normal value at least 6 h after the last use of a short acting β-agonist (SABA).
- Have stable asthma based on physician assessment at screening and prior to randomisation
- Subject must be otherwise healthy on the basis of a full medical examination including medical history, physical examination and laboratory tests performed at screening.
Who cannot join
- All subjects (Cohorts 1, 2, 3 \& 4)
- Any acute illness.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
- Use of prescription medications within 14 days of the Screening visit
- Are taking over the counter medications other than vitamins or multivitamins and herbal medication, within 14 days prior to Screening
- History of regular alcohol consumption within 6 months of the study of an average weekly intake of >21 units for males, or >14 units for females
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- Definite or suspected history of drug or alcohol abuse within the previous 5 years.
- A smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening
- A positive test for HIV-1 \& -2 antibodies at screening.
- A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- Positive test for alcohol, smoking or drugs of abuse, at screening or pre-dose
- Received an experimental drug or used an experimental medical device within 3 months before the first dose of the study drug is scheduled.
- Allergy to any of the active or inactive ingredients in the study medication.
- History of drug, or other allergy that would contraindicate participation.
- Donation of blood in excess of 500 mL within a 3 month period prior to dosing
- Mentally or legally incapacitated.
- An employee of the Sponsor or contract research organisation (CRO), or a relative of an employee of the Sponsor or CRO.
- Unable or unwilling to undergo multiple venepuncture procedures
- Pregnant or lactating female
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- Healthy Subjects (Cohorts 1, 2 \& 3)
- Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG
- Subjects with Asthma (Cohort 4)
- Has ever had an episode of life-threatening asthma defined as respiratory arrest, intubation for asthma, or ICU admission for asthma.
- Presence of clinically significant diseases other than asthma, hyper-responsive airways, seasonal allergic rhinitis or atopic diseases
- Has experienced an acute asthma exacerbation in the 12 months prior to screening requiring hospitalisation or accident and emergency treatment or management with systemic or injectable steroids.
- Has uncontrolled, or moderate to severe asthma based on PI assessment and/or use of prohibited medications, or has required treatment with these therapies in the previous 12 weeks.
- History or presence of any known conditions contraindicated for methacholine challenge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety and Tolerability of Single and Repeat, Inhaled Doses of PC786 in Healthy Subjects Combined With a Randomised, Single-blind, Placebo-controlled, Parallel Group to Assess the Safety and Tolerability of a Single Dose of Inhaled PC786 in Subjects With Mild Asthma
This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- PC786 - Single doses, Placebo - Single doses, PC786 - Repeat doses, Placebo - Repeat doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC786 - Single dosesDrug
Safety and tolerability of single doses
Placebo - Single dosesDrug
Safety and tolerability of single doses
PC786 - Repeat dosesDrug
Safety and tolerability of repeat doses
Placebo - Repeat dosesDrug
Safety and tolerability of repeat doses
| Study group | Role | What they receive |
|---|---|---|
| Single dose - healthy subjects | Experimental | Not described Receives: Drug: PC786 - Single doses; Drug: Placebo - Single doses |
| Repeat dose - healthy subjects | Experimental | Not described Receives: Drug: PC786 - Repeat doses; Drug: Placebo - Repeat doses |
| Single dose - subjects with asthma | Experimental | Not described Receives: Drug: PC786 - Single doses; Drug: Placebo - Single doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting one or more treatment-emergent adverse events (TEAE)
Measured: Baseline up to Week 12
Number of participants who discontinue due to an adverse event (AE)
Measured: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety 12-lead ECG assessment at least once post dose
Measured: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for vital signs assessment at least once post dose
Measured: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once once post dose
Measured: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety spirometry assessment (FEV1 & FVC - measured together) at least once once post dose
Measured: Baseline up to Week 12
Secondary outcomes (2)
Plasma concentration of PC786
Blood levels of PC786 measured after dosing
Measured: Day 1: Pre-dose and at multiple time points (up to 10 days) post final dose
Mucosal lining fluid concentration of PC786
PC786 concentration data in mucosal lining fluid measured after dosing
Measured: Cohort 1 - Day 1 = 3 samples; Day 2 = 2 samples; Day 3 = 1 sample. Cohorts 2 & 3 - Day 1 = 2 samples; Day 6 = 1 sample; Day 7 = 3 samples; Day 8 = 2 samples; Days 9 & 10 - 1 sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start21 Jun 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malcolm J Boyce, MBChB, MD, Principal investigator, cro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236233
- Sponsor's protocol ID
- PC_RSV_001
- Other IDs
- 2016-000934-22, 2016
- Status last verified
- Dec 2017
- First submitted
- 24 Jul 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety and Tolerability of Single and Repeat, Inhaled Doses of PC786 in Healthy Subjects Combined With a Randomised, Single-blind, Placebo-controlled, Parallel Group to Assess the Safety and Tolerability of a Single Dose of Inhaled PC786 in Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT03236233
- Acronym / sponsor ID
- PC_RSV_001
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Pulmocide LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 1 Aug 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.
This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose - healthy subjects | Experimental | Drug: PC786 - Single doses, Drug: Placebo - Single doses |
| Repeat dose - healthy subjects | Experimental | Drug: PC786 - Repeat doses, Drug: Placebo - Repeat doses |
| Single dose - subjects with asthma | Experimental | Drug: PC786 - Single doses, Drug: Placebo - Single doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All subjects (Cohorts 1, 2, 3 \& 4)
- Must be male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: women of childbearing potential who are willing and able to use contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
- Females must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urinary pregnancy test at Day -1.
- Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
Key exclusion criteria (28 listed)
- All subjects (Cohorts 1, 2, 3 \& 4)
- Any acute illness.
- Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
- Use of prescription medications within 14 days of the Screening visit
- Are taking over the counter medications other than vitamins or multivitamins and herbal medication, within 14 days prior to Screening
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 |
|---|---|---|
| PC786 - Single dosesSafety and tolerability of single doses | Drug | Single dose - healthy subjects, Single dose - subjects with asthma |
| Placebo - Single dosesSafety and tolerability of single doses | Drug | Single dose - healthy subjects, Single dose - subjects with asthma |
| PC786 - Repeat dosesSafety and tolerability of repeat doses | Drug | Repeat dose - healthy subjects |
| Placebo - Repeat dosesSafety and tolerability of repeat doses | Drug | Repeat dose - healthy subjects |
Primary outcome
Number of participants reporting one or more treatment-emergent adverse events (TEAE)
Time frame: Baseline up to Week 12
Number of participants who discontinue due to an adverse event (AE)
Time frame: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety 12-lead ECG assessment at least once post dose
Time frame: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for vital signs assessment at least once post dose
Time frame: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once once post dose
Time frame: Baseline up to Week 12
Number of participants who meet the markedly abnormal criteria for safety spirometry assessment (FEV1 & FVC - measured together) at least once once post dose
Time frame: Baseline up to Week 12
2 secondary outcomes
Plasma concentration of PC786
Time frame: Day 1: Pre-dose and at multiple time points (up to 10 days) post final dose
Mucosal lining fluid concentration of PC786
Time frame: Cohort 1 - Day 1 = 3 samples; Day 2 = 2 samples; Day 3 = 1 sample. Cohorts 2 & 3 - Day 1 = 2 samples; Day 6 = 1 sample; Day 7 = 3 samples; Day 8 = 2 samples; Days 9 & 10 - 1 sample
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 21 Dec 2017.
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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.
Malcolm J Boyce, MBChB, MD principal investigator
cro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PC786 - Single doses and PC786 - Repeat doses in people with Respiratory Syncytial Virus (RSV), 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 17 inclusion and 28 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 21 Dec 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Number of participants reporting one or more treatment-emergent adverse events (TEAE) (time frame: Baseline up to Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2017.