Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04606602
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2020-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'Day 150', 'description': 'safety and tolerability will be reported separately following single-dose administration.'}, {'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'Day 201', 'description': 'safety and tolerability will be reported separately following multiple-dose administration.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic: peak plasma concentration (Cmax)', 'timeFrame': 'Day 150 and Day 201', 'description': 'safety and tolerability will be reported separately following single-dose and multiple-dose administration.'}, {'measure': 'Pharmacokinetic: area under the plasma concentration (AUC)', 'timeFrame': 'Day 150 and Day 201', 'description': 'safety and tolerability will be reported separately following single-dose and multiple-dose administration.'}, {'measure': 'Pharmacokinetic: apparent total clearance from plasma after s.c injection (CL/F)', 'timeFrame': 'Day 150 and Day 201', 'description': 'safety and tolerability will be reported separately following single-dose and multiple-dose administration.'}, {'measure': 'Pharmacodynamic: Change in Lp(a)', 'timeFrame': 'Day 150 and Day 201', 'description': 'safety and tolerability will be reported separately following single-dose and multiple-dose administration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslipidemia, Dyslipoproteinemia, Hyperlipidemia, Hyperlipoproteinemia, Hyperlipoproteinemia (a), Lipoprotein, Lipoprotein (a)'], 'conditions': ['Hyperlipidemias', 'Dyslipidemias', 'Elevated Lp(a)']}, 'referencesModule': {'references': [{'pmid': '35368052', 'type': 'RESULT', 'citation': 'Nissen SE, Wolski K, Balog C, Swerdlow DI, Scrimgeour AC, Rambaran C, Wilson RJ, Boyce M, Ray KK, Cho L, Watts GF, Koren M, Turner T, Stroes ES, Melgaard C, Campion GV. Single Ascending Dose Study of a Short Interfering RNA Targeting Lipoprotein(a) Production in Individuals With Elevated Plasma Lipoprotein(a) Levels. JAMA. 2022 May 3;327(17):1679-1687. doi: 10.1001/jama.2022.5050.'}, {'pmid': '38587822', 'type': 'RESULT', 'citation': 'Nissen SE, Wolski K, Watts GF, Koren MJ, Fok H, Nicholls SJ, Rider DA, Cho L, Romano S, Melgaard C, Rambaran C. Single Ascending and Multiple-Dose Trial of Zerlasiran, a Short Interfering RNA Targeting Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2024 May 14;331(18):1534-1543. doi: 10.1001/jama.2024.4504.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety and tolerability of SLN360 in patients with elevated Lp(a).', 'detailedDescription': 'This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SLN360 after single ascending s.c. doses and multiple doses in healthy male and female subjects.\n\nUp to 9 cohorts of 88 patients with elevated Lp(a) will be enrolled. Each patient will receive single or multiple doses of SLN360 or placebo given by subcutaneous (s.c) injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Elevated plasma Lp(a) ≥ 150nmol/L.\n* All subjects must agree to adhere to appropriate contraception requirements.\n* Subjects must provide written informed consent and be able to comply with all study requirements.\n* Body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2.\n* For the MD part: confirmed history of stable atherosclerortic cardiovascular disease.\n\nExclusion criteria:\n\n* Single Ascending Dose only: any history of clinically overt cardiovascular disease, defined as acute coronary syndromes, myocardial infarction, stable angina, coronary or other revascularization, ischemic stroke or transient ischemic attack and atherosclerotic peripheral arterial disease.\n* Multiple Dose only: recent history of acute cardiovascular disease events within 6 months of screening (including, but not limited to, acute myocardial infarction, unstable angina, acute stroke and acute limb ischemia).\n* Moderate or severe hepatic cirrhosis with Child-Pugh grade B or C, or other current or previous liver disease.\n* Active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention.\n* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrolment in the study or could interfere with the subject's participation in, or completion of the study.\n* Subjects with previous or current use of medication or therapies significantly affecting Lp(a) level or hormone replacement therapy, unless on a stable dose for ≥ 8 weeks prior to screening\n* History or clinical evidence of alcohol or illegal drug misuse within the 6 months before screening.\n* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc, or intolerance to s.c. injections."}, 'identificationModule': {'nctId': 'NCT04606602', 'briefTitle': 'Study to Investigate Safety, Tolerability, PK and PD Response of SLN360 in Subjects With Elevated Lipoprotein(a)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Silence Therapeutics plc'}, 'officialTitle': 'A Randomised, Double-blind, Placebo Controlled, First-in-human Study to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of SLN360 in Subjects With Elevated Lipoprotein(a)', 'orgStudyIdInfo': {'id': 'SLN360-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 mg', 'interventionNames': ['Drug: SLN360']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '100 mg', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '300 mg', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '600 mg', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '900 mg', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '100 mg multi dose', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '200 mg multi dose', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '300 mg multi dose', 'interventionNames': ['Drug: SLN360']}, {'type': 'EXPERIMENTAL', 'label': '600 mg multi dose', 'interventionNames': ['Drug: SLN360']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo multi dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SLN360', 'type': 'DRUG', 'description': 'SLN360 for subcutaneous (s.c.) injection', 'armGroupLabels': ['100 mg', '100 mg multi dose', '200 mg multi dose', '30 mg', '300 mg', '300 mg multi dose', '600 mg', '600 mg multi dose', '900 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sodium chloride for subcutaneous (s.c.) injection', 'armGroupLabels': ['Placebo', 'Placebo multi dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research Ltd.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metabolic and Atherosclerosis Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Clayton', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silence Therapeutics plc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}