Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 2:55 PM
Study NCT ID:
NCT06633757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Inhaled RCT1100 in Adults With PCD Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002925', 'term': 'Ciliary Motility Disorders'}, {'id': 'D007619', 'term': 'Kartagener Syndrome'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D015619', 'term': 'Respiratory System Abnormalities'}, {'id': 'D003914', 'term': 'Dextrocardia'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D012857', 'term': 'Situs Inversus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the impact of multiple doses of RCT1100 on MCC', 'timeFrame': 'Baseline through Week 12', 'description': 'The Change in Mucociliary and Cough Clearance through 1 hour after radiotracer administration by either the albumin-based PRMC or sulfur-colloid technique'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary ciliary Dyskinesia', 'PCD', 'Kartagener Syndrome'], 'conditions': ['Primary Ciliary Dyskinesia (PCD)']}, 'descriptionModule': {'briefSummary': 'This is a multi-dose study with RCT1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.', 'detailedDescription': 'The primary objective of this study is to determine the impact of multiple doses of inhaled RCT1100, administered via nebulizer, on MCC with adult participants with Primary Ciliary Dyskinesia caused by pathogenic mutations in the DNAI1 Gene.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* The participant is a male or female, 18 to 75 years of age, inclusive, at the time of consent.\n* Participant has disease-causing (pathogenic and/or likely pathogenic) mutations in the DNAI1 gene.\n* The participant has a percent predicted forced expiratory volume in 1 second (FEV1pp) of at least 40% predicted.\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.\n* History of cancer, with exception of adequately treated basal cell or squamous cell carcinoma of the skin.\n* Predisposition to bleeding or clinically meaningful hemorrhagic event in the 12 months prior\n* Medically significant hemoptysis.\n* Anticoagulation therapy for the treatment of a pulmonary embolus or has had a pulmonary embolus in the last 6 months of screening.\n* Active tuberculosis infection.\n* 12-lead ECG with QT interval \\>450 msec (or \\>480 msec for BBB)\n* Laboratory abnormalities in clinical laboratory tests at screening:\n\n 1. Serum creatinine level\n 2. Total bilirubin, aspartate aminotransferase or alanine aminotransferase values\n 3. Hematological or coagulation values outside the normal reference range\n* Any medical history of disease that has the potential to cause a rise in total bilirubin over the ULN.\n* COVID-19 infection within 4 weeks of Screening or receipt of COVID-19 vaccine within 2 weeks prior to first dose of RCT1100.\n* Receipt of vaccine with live virus, attenuated live virus, or live viral components within 2 weeks prior to first dose of RCT1100 or to receive these vaccines during treatment or within 8 weeks of completion of study treatment.\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06633757', 'briefTitle': 'Study of Inhaled RCT1100 in Adults With PCD Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReCode Therapeutics'}, 'officialTitle': 'A Phase 1b, Open-label, Study of RCT1100 in Adults With Primary Ciliary Dyskinesia Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance and Other Measures of Pharmacodynamic Activity', 'orgStudyIdInfo': {'id': 'RCT1100-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCD Participants', 'description': 'RCT1100 mRNA therapy supplied to eligible participants with Primary Ciliary Dyskinesia caused by disease-causing mutations in the DNAI1 gene', 'interventionNames': ['Drug: RCT1100']}], 'interventions': [{'name': 'RCT1100', 'type': 'DRUG', 'description': 'mRNA therapy supplied as varying dose strengths administered via oral inhalation using nebulizer', 'armGroupLabels': ['PCD Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital - Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Münster University Hospital, Albert-Schweitzer-Campus 1', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'John Matthews, MBBS, MCRP, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ReCode Therapeutics, Inc.'}, {'name': 'Heymut Omran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster'}, {'name': 'Kim G Nielsen, Dr Med Sci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReCode Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}