Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT04111666
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2019-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)', 'timeFrame': 'either 57, 113, or 141 days, depending on the cohort', 'description': 'Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of AL101', 'timeFrame': 'either 57, 113, or 141 days, depending on the cohort', 'description': 'Serum and CSF concentration of AL101 at specified time points'}, {'measure': 'Maximum plasma concentration (Cmax) for AL101', 'timeFrame': 'either 57, 113, or 141 days, depending on the cohort', 'description': 'Evaluate Cmax for serum and CSF concentration of AL101 at specified time points'}, {'measure': 'Area under the curve concentration (AUC) for AL101', 'timeFrame': 'either 57, 113, or 141 days, depending on the cohort', 'description': 'Evaluate AUC for serum and CSF concentration of AL101 at specified time points'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '40713730', 'type': 'DERIVED', 'citation': "Budda B, Mitra A, Park L, Long H, Kurnellas M, Bien-Ly N, Estacio W, Burgess B, Chao G, Schwabe T, Paul R, Kenkare-Mitra S, Rosenthal A. Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer's disease. Alzheimers Res Ther. 2025 Jul 25;17(1):174. doi: 10.1186/s13195-025-01817-4."}]}, 'descriptionModule': {'briefSummary': 'A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics', 'detailedDescription': 'This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 18.0-35.0 kg/m2\n* 45-120 kg, inclusive\n* At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.\n* Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.\n* In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.\n* Willingness and able to comply with the study protocol, in the investigator's judgement.\n\nExclusion Criteria:\n\n* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.\n* Positive drug or alcohol at screening and prior to first dose\n* History of alcohol abuse or substance abuse"}, 'identificationModule': {'nctId': 'NCT04111666', 'briefTitle': 'A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alector Inc.'}, 'officialTitle': 'A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101', 'orgStudyIdInfo': {'id': 'AL101-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL101 IV', 'description': '* Up to four single ascending doses (SAD IV cohorts)\n* Multiple doses of AL101 administered IV (MD IV cohort)', 'interventionNames': ['Biological: AL101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Solution', 'description': 'Saline solution will be administered with the following:\n\n* Single IV infusion for four single ascending doses (SAD IV cohorts) in a ratio of 8 active and 3 placebo subjects\n* Multiple IV infusions for the MD IV cohort in a ratio of 8 active and 2 placebo subjects', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AL101 SC', 'description': '* Single fixed dose levels of AL101 administered SC\n* Multiple fixed dose of AL101 administered SC', 'interventionNames': ['Biological: AL101']}], 'interventions': [{'name': 'AL101', 'type': 'BIOLOGICAL', 'description': 'Active dose of AL101', 'armGroupLabels': ['AL101 IV', 'AL101 SC']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline solution administered as a single and multiple infusion as placebo.', 'armGroupLabels': ['Saline Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Study site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Jorge Kusnir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bioclinica Research'}, {'name': 'Maria Bermudez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alector Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}