Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT06659757
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)', 'timeFrame': 'Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD', 'description': 'Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.', 'detailedDescription': 'This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.\n2. Adult males and females, 18 to 55 years of age (inclusive) at screening.\n3. BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.\n4. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.\n5. Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.70.\n\nMajor Exclusion Criteria:\n\n1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant.\n2. Any respiratory infection or relevant respiratory problem within 14 days of Day 1.\n\nOther inclusion/exclusion eligibility criteria apply.'}, 'identificationModule': {'nctId': 'NCT06659757', 'briefTitle': 'A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kither Biotech Srl'}, 'officialTitle': 'A Single-Centre, Double-Blinded, Randomised, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'KIT2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Single Ascending Dose (SAD)', 'description': 'Healthy volunteers - Up to 4 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A4) of 8 healthy participants per cohort (ratio 3:1 active:placebo).', 'interventionNames': ['Drug: KIT2014', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Multiple Ascending Dose (MAD)', 'description': 'Healthy volunteers - Up to 3 dose levels of KIT2014 will be evaluated in Part B. Dose levels will be investigated in sequential cohorts (B1 to B3) of 8 healthy participants per cohort (ratio 3:1 active:placebo).', 'interventionNames': ['Drug: KIT2014', 'Other: Placebo']}], 'interventions': [{'name': 'KIT2014', 'type': 'DRUG', 'description': 'KIT2014 will be administered by inhalation with a nebuliser', 'armGroupLabels': ['Part A: Single Ascending Dose (SAD)', 'Part B: Multiple Ascending Dose (MAD)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be administered by inhalation with a nebuliser', 'armGroupLabels': ['Part A: Single Ascending Dose (SAD)', 'Part B: Multiple Ascending Dose (MAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX Clinical Research Pty Ltd', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kither Biotech Srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Avance Clinical Pty Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}