Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-03 @ 10:05 AM
Study NCT ID:
NCT02245828
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2014-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-20', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '39 days', 'description': 'Number of Participants with Adverse Events'}], 'secondaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': '39 days', 'description': 'Area under the plasma concentration-time curve from time zero to infinity'}, {'measure': 'AUClast', 'timeFrame': '39 days', 'description': 'The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration'}, {'measure': 'AUCtau', 'timeFrame': '39 days', 'description': 'The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau'}, {'measure': 'Cav', 'timeFrame': '39 days', 'description': 'The average steady state plasma concentration during multiple dosing'}, {'measure': 'Cmax', 'timeFrame': '39 days', 'description': 'The observed maximum plasma concentration following drug administration'}, {'measure': 'T1/2', 'timeFrame': '39 days', 'description': 'The terminal elimination half life'}, {'measure': 'Tmax', 'timeFrame': '39 days', 'description': 'The time to reach the maximum concentration after drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy subjects, inhaled'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent must be obtained before any assessment is performed.\n2. Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.\n3. Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \\[Height (m)\\]2.\n4. Oxygen saturation (O2) at screening must be ≥ 95% on room air.\n5. FEV1 ≥ 90% predicted.\n\nExclusion Criteria:\n\n1. 1\\. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.\n2. History of asthma or reactive airway diseases.\n3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.\n4. History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n5. Women of child-bearing potential'}, 'identificationModule': {'nctId': 'NCT02245828', 'briefTitle': 'A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled First-in-human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CQCC374X2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'QCC374', 'description': 'Single and multiple ascending doses of QCC374', 'interventionNames': ['Drug: QCC374']}], 'interventions': [{'name': 'QCC374', 'type': 'DRUG', 'description': 'Single and multiple ascending doses of QCC374', 'armGroupLabels': ['QCC374']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF484DR', 'city': 'Mid Glamorgan', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}