Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT03236233
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626983', 'term': 'PC-786'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants reporting one or more treatment-emergent adverse events (TEAE)', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of participants who discontinue due to an adverse event (AE)', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for safety 12-lead ECG assessment at least once post dose', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for vital signs assessment at least once post dose', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once once post dose', 'timeFrame': 'Baseline up to Week 12'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for safety spirometry assessment (FEV1 & FVC - measured together) at least once once post dose', 'timeFrame': 'Baseline up to Week 12'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of PC786', 'timeFrame': 'Day 1: Pre-dose and at multiple time points (up to 10 days) post final dose', 'description': 'Blood levels of PC786 measured after dosing'}, {'measure': 'Mucosal lining fluid concentration of PC786', 'timeFrame': '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', 'description': 'PC786 concentration data in mucosal lining fluid measured after dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus (RSV)']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects (Cohorts 1, 2, 3 \\& 4)\n\n* 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.\n* Females must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urinary pregnancy test at Day -1.\n* Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.\n* 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.\n* Body weight ≥ 50 kg and body mass index (BMI) within the range 18 - 30 kg/m2 (inclusive).\n* Average QTcF \\<450 msec at screening and pre-dose.\n* Vital signs assessments within normal ranges at screening and pre-dose.\n\nHealthy Subjects (Cohorts 1, 2 \\& 3)\n\n* 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.\n* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio \\> 0.7 at screening\n\nSubjects with Asthma (Cohort 4)\n\n* Documented diagnosis of asthma, first diagnosed at least 12 months prior to the screening visit.\n* Subject must demonstrate a PC20 methacholine ≤ 8 mg/mL at the screening visit.\n* Have an FEV1 \\>60% of predicted normal value at least 6 h after the last use of a short acting β-agonist (SABA).\n* Have stable asthma based on physician assessment at screening and prior to randomisation\n* Subject must be otherwise healthy on the basis of a full medical examination including medical history, physical examination and laboratory tests performed at screening.\n\nExclusion Criteria:\n\nAll subjects (Cohorts 1, 2, 3 \\& 4)\n\n* Any acute illness.\n* Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.\n* Use of prescription medications within 14 days of the Screening visit\n* Are taking over the counter medications other than vitamins or multivitamins and herbal medication, within 14 days prior to Screening\n* 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\n* Definite or suspected history of drug or alcohol abuse within the previous 5 years.\n* A smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening\n* A positive test for HIV-1 \\& -2 antibodies at screening.\n* A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.\n* Positive test for alcohol, smoking or drugs of abuse, at screening or pre-dose\n* Received an experimental drug or used an experimental medical device within 3 months before the first dose of the study drug is scheduled.\n* Allergy to any of the active or inactive ingredients in the study medication.\n* History of drug, or other allergy that would contraindicate participation.\n* Donation of blood in excess of 500 mL within a 3 month period prior to dosing\n* Mentally or legally incapacitated.\n* An employee of the Sponsor or contract research organisation (CRO), or a relative of an employee of the Sponsor or CRO.\n* Unable or unwilling to undergo multiple venepuncture procedures\n* Pregnant or lactating female\n* Any other reason that the Investigator considers makes the subject unsuitable to participate.\n\nHealthy Subjects (Cohorts 1, 2 \\& 3)\n\n* Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG\n\nSubjects with Asthma (Cohort 4)\n\n* Has ever had an episode of life-threatening asthma defined as respiratory arrest, intubation for asthma, or ICU admission for asthma.\n* Presence of clinically significant diseases other than asthma, hyper-responsive airways, seasonal allergic rhinitis or atopic diseases\n* 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.\n* 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.\n* History or presence of any known conditions contraindicated for methacholine challenge'}, 'identificationModule': {'nctId': 'NCT03236233', 'briefTitle': 'A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmocide Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PC_RSV_001'}, 'secondaryIdInfos': [{'id': '2016-000934-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose - healthy subjects', 'interventionNames': ['Drug: PC786 - Single doses', 'Drug: Placebo - Single doses']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat dose - healthy subjects', 'interventionNames': ['Drug: PC786 - Repeat doses', 'Drug: Placebo - Repeat doses']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose - subjects with asthma', 'interventionNames': ['Drug: PC786 - Single doses', 'Drug: Placebo - Single doses']}], 'interventions': [{'name': 'PC786 - Single doses', 'type': 'DRUG', 'description': 'Safety and tolerability of single doses', 'armGroupLabels': ['Single dose - healthy subjects', 'Single dose - subjects with asthma']}, {'name': 'Placebo - Single doses', 'type': 'DRUG', 'description': 'Safety and tolerability of single doses', 'armGroupLabels': ['Single dose - healthy subjects', 'Single dose - subjects with asthma']}, {'name': 'PC786 - Repeat doses', 'type': 'DRUG', 'description': 'Safety and tolerability of repeat doses', 'armGroupLabels': ['Repeat dose - healthy subjects']}, {'name': 'Placebo - Repeat doses', 'type': 'DRUG', 'description': 'Safety and tolerability of repeat doses', 'armGroupLabels': ['Repeat dose - healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Malcolm J Boyce, MBChB, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'cro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmocide Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}