Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06363851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-ascending Dose Study of Kylo-11 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'up to Week 24'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'up to week 48'}, {'measure': 'Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)', 'timeFrame': 'up to Week 48'}, {'measure': 'PK parameter of time of maximum observed concentration (Tmax)', 'timeFrame': 'up to Week 48'}, {'measure': 'PK parameter of area under the concentration time curve (AUC)', 'timeFrame': 'up to Week 48'}, {'measure': 'Change in serum Lp(a) over time', 'timeFrame': 'up to Week 48'}, {'measure': 'Percent change in serum Lp(a) over time', 'timeFrame': 'up to Week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 55 years old, inclusive;\n* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;\n* Protocol-defined elevated serum Lp(a) level;\n* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;\n* Willing to comply with protocol required visits and assessments, and provide written informed consent.\n\nExclusion Criteria:\n\n* History or evidence of a clinically significant disorder, condition or disease;\n* Received an investigational drug, vaccine or device within 3 months before dosing;\n* History of evidence of malignant tumor or Gilbert syndrome;\n* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;\n* History of alcohol abuse within 12 months before dosing;\n* History of drug abuse within 3 months before screening;\n* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;\n* History of stroke or myocardial infarction within 6 months before sceening;\n* Pregnant or breast-feeding women;\n* Other exclusion criteria applied per protocol.'}, 'identificationModule': {'nctId': 'NCT06363851', 'briefTitle': 'Single-ascending Dose Study of Kylo-11 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kylonova (Xiamen) Biopharma co., LTD.'}, 'officialTitle': 'A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'Kylo-11-I-C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kylo-11', 'description': 'Single ascending doses of Kylo-11 administered subcutaneously (SC).', 'interventionNames': ['Drug: Kylo-11']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Kylo-11', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Kylo-11']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu Xinhua Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kylonova (Xiamen) Biopharma co., LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}