Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT05047458
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Single-dose ALXN2050 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020742', 'term': 'rhoA GTP-Binding Protein'}], 'ancestors': [{'id': 'D020741', 'term': 'rho GTP-Binding Proteins'}, {'id': 'D020559', 'term': 'Monomeric GTP-Binding Proteins'}, {'id': 'D019204', 'term': 'GTP-Binding Proteins'}, {'id': 'D020558', 'term': 'GTP Phosphohydrolases'}, {'id': 'D017766', 'term': 'Acid Anhydride Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Of Participants Experiencing Serious Adverse Events', 'timeFrame': 'Day 1 through Day 42'}, {'measure': 'Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)', 'timeFrame': 'Day 1 through Day 42'}, {'measure': 'Number Of Participants Experiencing AEs Leading To Discontinuation From The Study', 'timeFrame': 'Day 1 through Day 42'}, {'measure': 'Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities', 'timeFrame': 'Day 1 through Day 42'}, {'measure': 'Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Day 1 through Day 42'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) Of ALXN2050', 'timeFrame': 'Up to 144 hours postdose'}, {'measure': 'Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050', 'timeFrame': 'Up to 144 hours postdose'}, {'measure': 'Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050', 'timeFrame': 'Up to 144 hours postdose'}, {'measure': 'Alternative Pathway (AP) Activity As Measured By Wieslab Assay', 'timeFrame': 'Up to 144 hours postdose'}, {'measure': 'Plasma Bb Fragment Of Complement Factor B Concentration Over Time', 'timeFrame': 'Up to 144 hours postdose'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Factor D Inhibitor', 'Complement', 'ALXN2050', 'ACH-0145228', 'Pharmacokinetics', 'Pharmacodynamics', 'Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.\n* Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.\n* Female participant of nonchildbearing potential.\n* Male participant agreed to abstinence or use of a highly effective form of contraception.\n\nKey Exclusion Criteria:\n\n* Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.\n* Had any condition possibly affecting drug absorption.\n* Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.\n* Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.\n* Had participated in a clinical study within 30 days prior to first study drug administration\n* Had clinically significant laboratory abnormalities,\n* Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.\n* Had a clinically significant history of drug allergy.'}, 'identificationModule': {'nctId': 'NCT05047458', 'briefTitle': 'A Study of Single-dose ALXN2050 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ACH228-001'}, 'secondaryIdInfos': [{'id': 'ACTRN12617001521314', 'type': 'OTHER', 'domain': 'Australian New Zealand Clinical Trials Registry'}, {'id': 'U1111-1203-1371', 'type': 'OTHER', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: 40 mg ALXN2050/Placebo', 'description': 'Participants randomized to receive ALXN2050 or placebo on Day 1.', 'interventionNames': ['Drug: ALXN2050', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: 80 mg ALXN2050/Placebo', 'description': 'Participants randomized to receive ALXN2050 or placebo on Day 1.', 'interventionNames': ['Drug: ALXN2050', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: 120 mg ALXN2050/Placebo', 'description': 'Participants randomized to receive ALXN2050 or placebo on Day 1.', 'interventionNames': ['Drug: ALXN2050', 'Drug: Placebo']}], 'interventions': [{'name': 'ALXN2050', 'type': 'DRUG', 'otherNames': ['ACH-0145228 (formerly)', 'ACH-5228'], 'description': 'Powder-in-capsule (PIC).', 'armGroupLabels': ['Cohort 1: 40 mg ALXN2050/Placebo', 'Cohort 2: 80 mg ALXN2050/Placebo', 'Cohort 3: 120 mg ALXN2050/Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PIC.', 'armGroupLabels': ['Cohort 1: 40 mg ALXN2050/Placebo', 'Cohort 2: 80 mg ALXN2050/Placebo', 'Cohort 3: 120 mg ALXN2050/Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Achillion, a wholly owned subsidiary of Alexion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}