Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05779995
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719812', 'term': 'XW001'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events after receiving XW001', 'timeFrame': 'Day 1 to Day 28'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in RSV load via nasopharyngeal swab', 'timeFrame': 'Baseline, Day 2 to Day 8'}, {'measure': 'Change from baseline in Wang Respiratory Score', 'timeFrame': 'Baseline, Day 2 to Day 8'}, {'measure': 'Pharmacokinetics-Plasma level of XW001', 'timeFrame': 'Baseline, Day 8'}, {'measure': 'Immunogenicity-Anti-drug Antibody of XW001', 'timeFrame': 'Baseline, Day 28'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XW001', 'Respiratory Syncytial Virus'], 'conditions': ['RSV Infection']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China', 'detailedDescription': 'In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 1 to 24 months (inclusive) at screening;\n2. Weight: 3-20 kg, inclusive;\n3. Positive RSV test within 36 hours before randomization;\n4. Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;\n5. Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.\n\nExclusion Criteria:\n\n1. Immunocompromised as determined by the investigator;\n2. Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;\n3. Positive for HBV, HCV or HIV, or patient \\<6 months old whose mother is positive for HIV;\n4. History of seizures or epilepsy, including febrile seizure;\n5. Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;\n6. History of any surgery within 30 days prior to randomization;\n7. Severe dental or facial deformity that will impact on usage of nebulizer;\n8. History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening;\n9. Known to have received any investigational medicinal products or devices in the past 30 days;\n10. Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT05779995', 'briefTitle': 'A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Sciwind Biosciences Co., Ltd.'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Phase Ib/Ⅱa Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of XW001 Inhalation in Children With Respiratory Syncytial Virus (RSV) Infection in China', 'orgStudyIdInfo': {'id': 'SCW1201-3021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C1-XW001', 'description': 'Low dose of XW001 once daily', 'interventionNames': ['Drug: XW001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C1-Placebo', 'description': 'Matched Placebo once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C2-XW001', 'description': 'Medium dose of XW001 once daily', 'interventionNames': ['Drug: XW001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C2-Placebo', 'description': 'Matched Placebo once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C3-XW001', 'description': 'High dose of XW001 once daily', 'interventionNames': ['Drug: XW001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C3-Placebo', 'description': 'Matched Placebo once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'XW001', 'type': 'DRUG', 'description': 'Inhalation solution', 'armGroupLabels': ['C1-XW001', 'C2-XW001', 'C3-XW001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inhalation solution with matched volume', 'armGroupLabels': ['C1-Placebo', 'C2-Placebo', 'C3-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Second University Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Hanmin Liu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Second University Hospital'}, {'name': 'Qin Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Second University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Sciwind Biosciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}