Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT05896969
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a Phase 1, multi-center, randomized, double-blind, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C. The study will be divided into two parts:\n\n* SAD cohorts;\n* MAD cohorts. The two parts will be completed sequentially. The MAD part may be initiated when safety, tolerability, and PK data are known and deemed acceptable for single doses of at least the 5 planned dose levels of the SAD cohorts.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent adverse events', 'timeFrame': 'SAD - Up to Day 57 (end of study visit)', 'description': 'Number of Subjects with Treatment Emergent Adverse Events'}, {'measure': 'Treatment emergent adverse events', 'timeFrame': 'MAD - Up to Day 85 (end of study visit)', 'description': 'Number of Subjects with Treatment Emergent Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'Cmax will be assessd'}, {'measure': 'Pharmacokinetic Assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'tmax will be assessd'}, {'measure': 'Pharmacokinetic Assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'AUC will be assessd'}, {'measure': 'Pharmacokinetic Assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'T 1/2 will be assessd'}, {'measure': 'Pharmacodynamic (PD) effect assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'LDL-C serum concentration will be assessed.'}, {'measure': 'Pharmacodynamic (PD) effect assessment', 'timeFrame': 'Upto Day 57 for SAD , Upto Day 85 for MAD', 'description': 'PCSK9 plasma levels concentration will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elevated Low-Density Lipoprotein Cholesterol']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C. The study will be divided into two parts:\n\n* SAD cohorts\n* MAD cohorts', 'detailedDescription': 'The SAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive)\n\nThe MAD part will consist of up to 8 cohorts of eligible participants with elevated LDL-C as defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria -\n\n1. Male or female, ≥18 and ≤65 years of age, with BMI ≥18.5 and ≤35.0 kg/m2.\n2. Participants must be either non smoking (no use of tobacco or nicotine products within 3 months prior to screening) or social smoker as defined by smoking no more than 5 cigarettes (or nicotine equivalent) a week and no smoking during screening period or on study.\n3. Participants must be with elevated LDL-C defined as serum LDL levels between 2.6 - 4.9 mmol/L (inclusive) at screening.\n4. Healthy (except for the LDL-C status) participants.\n5. Participants must have fasting triglyceride level \\<4.52 mmol/L (\\<400mg/dL) at screening.\n6. Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study as detailed in section 8.1.\n7. Able to understand the study procedures and provide signed informed consent to participate in the study.\n\nExclusion Criteria -\n\n1. Any clinically significant abnormal finding at physical examination in the opinion of the investigator.\n2. Subjects with a history or presence of cardiovascular disease (including cerebrovascular accident (stroke or TIA) or disease, uncontrolled hypertension, familial hypercholesterolaemia, obstructive sleep apnoea, and peripheral artery), a diagnosis of diabetes mellitus given potential for hyperglycaemia defined as HbA1c greater or equal to 6.5%, or a non-alcoholic fatty liver disease.\n3. Received Leqvio (inclisiran) treatment in less than 6 months ago.\n4. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.'}, 'identificationModule': {'nctId': 'NCT05896969', 'briefTitle': 'Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol', 'organization': {'class': 'OTHER', 'fullName': 'Syneos Health'}, 'officialTitle': 'Phase 1, Single Multiple Dose Escalation Study in a Randomized, Double-blind, Placebo Controlled Design to Investigate Safety, Tolerability, PK and PD of SC Administered SNK-396 in Subjects With Elevated Low-Density Lipoprotein Cholesterol', 'orgStudyIdInfo': {'id': 'SNK-396-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD Cohort', 'description': 'SAD Cohort 1 - 8 : Subjects in each cohort will be randomised will receive a single SC dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.', 'interventionNames': ['Drug: SNK-396 - SAD cohort']}, {'type': 'EXPERIMENTAL', 'label': 'MAD cohort', 'description': 'MAD Cohort 1 - 8 : Subjects in each cohort will be randomized will receive the active SNK-396 with dose range of SNK-396 anticipated to be from 25 to 800 mg or matching placebo', 'interventionNames': ['Drug: SNK-396 - MAD Cohort']}], 'interventions': [{'name': 'SNK-396 - SAD cohort', 'type': 'DRUG', 'description': 'A single dose of SNK-396 within the dose range of 25 to 800 mg, or matching placebo.', 'armGroupLabels': ['SAD Cohort']}, {'name': 'SNK-396 - MAD Cohort', 'type': 'DRUG', 'description': 'Multiple doses of SNK-396 within the dose range of from 25 to 800 mg, or matching placebo.', 'armGroupLabels': ['MAD cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nucleus Network Pty Ltd', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Cmax Clinical Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network Pty Ltd', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syneos Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'SynerK Pharmatech (Suzhou) Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}