Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04488705
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2020-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants reporting one or more treatment emergent adverse event (TEAE)', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Number of participants who discontinue due to an adverse event (AE)', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose', 'timeFrame': 'Baseline to Week 8'}, {'measure': 'Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose', 'timeFrame': 'Baseline to Week 8'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of ETD002', 'timeFrame': 'Day 1 pre-dose and at multiple time points (up to 14 days) post final dose', 'description': 'Blood levels of ETD002 measured after dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic fibrosis'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '41318901', 'type': 'DERIVED', 'citation': 'Miller P, Repplinger D, Zhu R, Chen Y, Lewin-Koh N, Morris D, Russell P, She G, Singh N, White R, Wilkes D, Chen H, Galanter J. Randomized, phase I studies to evaluate the safety, tolerability, and pharmacokinetics of an inhaled, TMEM16A potentiator, GDC-6988, in healthy subjects. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251393346. doi: 10.1177/17534666251393346. Epub 2025 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males \\& females using suitable methods of contraception or females of non-childbearing potential\n* Consent to study participation\n* Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2\n* Vital signs assessments within normal ranges\n* Healthy as determined following physical examination at screening visit\n* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value\n\nExclusion Criteria:\n\n* Acute or chronic illness detected at screening visit\n* Respiratory tract infection within 4 weeks of the screening visit\n* Use of prescription or OTC medication within 14 days of the screening visit\n* History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse\n* Smoking or use of tobacco products within 6 months of screening\n* Abnormal blood/urine laboratory screening test results\n* Current, or history of, allergy that may be contraindicated'}, 'identificationModule': {'nctId': 'NCT04488705', 'briefTitle': 'A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enterprise Therapeutics Ltd'}, 'officialTitle': 'A First in Human, Randomised, Double Blind, Placebo-controlled, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'ET-TMEM-01'}, 'secondaryIdInfos': [{'id': '2020-001080-92', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single ascending dose', 'interventionNames': ['Drug: ETD002 - single dose', 'Drug: Placebo - single dose']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat dose - 7 days', 'interventionNames': ['Drug: ETD002 - 7 day repeat dose', 'Drug: Placebo - 7 day repeat dose']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat dose - 14 days', 'interventionNames': ['Drug: ETD002 - 14 day repeat dose', 'Drug: Placebo - 14 day repeat dose']}, {'type': 'EXPERIMENTAL', 'label': 'Repeat dose - 7 days with SABA', 'interventionNames': ['Drug: ETD002 - 7 day repeat dose', 'Drug: Placebo - 7 day repeat dose', 'Drug: Salbutamol']}], 'interventions': [{'name': 'ETD002 - single dose', 'type': 'DRUG', 'description': 'Single ascending doses of ETD002', 'armGroupLabels': ['Single ascending dose']}, {'name': 'Placebo - single dose', 'type': 'DRUG', 'description': 'Single doses of placebo', 'armGroupLabels': ['Single ascending dose']}, {'name': 'ETD002 - 7 day repeat dose', 'type': 'DRUG', 'description': 'Twice daily doses of ETD002 for 7 days', 'armGroupLabels': ['Repeat dose - 7 days', 'Repeat dose - 7 days with SABA']}, {'name': 'Placebo - 7 day repeat dose', 'type': 'DRUG', 'description': 'Twice daily doses of Placebo for 7 days', 'armGroupLabels': ['Repeat dose - 7 days', 'Repeat dose - 7 days with SABA']}, {'name': 'ETD002 - 14 day repeat dose', 'type': 'DRUG', 'description': 'Twice daily doses of ETD002 for 14 days', 'armGroupLabels': ['Repeat dose - 14 days']}, {'name': 'Placebo - 14 day repeat dose', 'type': 'DRUG', 'description': 'Twice daily doses of Placebo for 14 days', 'armGroupLabels': ['Repeat dose - 14 days']}, {'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Twice daily doses of salbutamol for 3 days (Days 5, 6 \\& 7)', 'armGroupLabels': ['Repeat dose - 7 days with SABA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David Morris, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Enterprise Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enterprise Therapeutics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}