Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06238856
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2024-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2005-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2005-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who Experience a Treatment Emergent Adverse Event (TEAE)', 'timeFrame': 'Up to Day 28', 'description': 'Safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve (AUC) of SLIT™ Amikacin in Serum', 'timeFrame': 'Pre-dose and at multiple time points post-dose up to Day 3'}, {'measure': 'Percent Dose of SLIT™ Amikacin in Urine', 'timeFrame': 'At multiple time points post-dose up to Day 3'}, {'measure': 'AUC of SLIT™ Amikacin in Sputum', 'timeFrame': 'Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 14, and 28'}, {'measure': 'Change From Baseline in Sputum Density of Pseudomonas Aeruginosa', 'timeFrame': 'Baseline up to Day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study participants must produce sputum that is positive for Pseudomonas aeruginosa.\n* Confirmed diagnosis of CF (positive sweat chloride \\>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype.\n* Forced expiratory volume (FEV1) ≥40% predicted at Screening as calculated by the Knudsen reference equations.\n* Clinically stable with no evidence of current pulmonary exacerbation.\n\nExclusion Criteria:\n\n* History of lung transplantation.\n* Use of intravenous antibiotics or oral quinolones within 14 days of Screening.\n* Use of low dose oral antibiotics (e.g. tetracycline, sulfa) for acne or other conditions within 30 days of Screening.\n* Use of systemic corticosteroids (≥20 milligrams \\[mg\\] of prednisone per day) within 30 days of Screening.\n* Initiation of TOBI® (tobramycin), high dose ibuprofen, recombinant human DNase (rhDNase), or macrolide antibiotics within 60 days of Screening.\n* History of sputum or throat swab culture yielding Burkholderia cepacia complex within 2 years of Screening or growth of Burkholderia cepacia complex from the sputum or throat swab culture obtained at Screening.\n* History of biliary cirrhosis, portal hypertension, or splenomegaly or splenomegaly on physical exam at Screening or enrollment.\n* History of daily continuous oxygen supplementation or requirement for more than 2 liter per minute (L/min) at night.\n\nNote: Other inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06238856', 'briefTitle': 'Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'Safety and Tolerability Study of Single Dose Escalations of TR02 (SLIT™ Amikacin) by Inhalation in Cystic Fibrosis Study Patients With Chronic Infections of Pseudomonas Aeruginosa', 'orgStudyIdInfo': {'id': 'TR02-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Amikacin Dose 1 + Placebo', 'description': 'Participants will receive a single dose of SLIT™ amikacin at Dose 1 or matching placebo by inhalation on Day 0.', 'interventionNames': ['Drug: SLIT™ Amikacin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Amikacin Dose 2 + Placebo', 'description': 'Participants will receive a single dose of SLIT™ amikacin at Dose 2 or matching placebo by inhalation on Day 0 upon initiation of Cohort 2.', 'interventionNames': ['Drug: SLIT™ Amikacin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Amikacin Dose 3 + Placebo', 'description': 'Participants will receive a single dose of SLIT™ amikacin at Dose 3 or matching placebo by inhalation on Day 0 upon initiation of Cohort 3.', 'interventionNames': ['Drug: SLIT™ Amikacin', 'Drug: Placebo']}], 'interventions': [{'name': 'SLIT™ Amikacin', 'type': 'DRUG', 'otherNames': ['TR02'], 'description': 'Amikacin administered via the Pari LC STAR™ nebulizer.', 'armGroupLabels': ['Cohort 1: Amikacin Dose 1 + Placebo', 'Cohort 2: Amikacin Dose 2 + Placebo', 'Cohort 3: Amikacin Dose 3 + Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Nebulized saline.', 'armGroupLabels': ['Cohort 1: Amikacin Dose 1 + Placebo', 'Cohort 2: Amikacin Dose 2 + Placebo', 'Cohort 3: Amikacin Dose 3 + Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insmed Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}