Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT04689035
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004341', 'term': 'Drug Evaluation'}], 'ancestors': [{'id': 'D000076722', 'term': 'Drug Development'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of AVLX-144', 'timeFrame': 'From randomisation to end of study participation', 'description': 'Safety and tolerability will be assessed by recording adverse events (AEs), by performing physical examinations and safety laboratory assessments (blood and urine), and by recording vital signs and electrocardiograms (ECGs).'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics parameter', 'timeFrame': 'From dosing until 48 hours after dosing', 'description': 'AUClast (the area under the plasma concentration-time curve from time zero to the last sample with a quantifiable concentration)'}, {'measure': 'Pharmacokinetics parameter', 'timeFrame': '24 hrs', 'description': 'AUC0-24 (the area under the plasma concentration-time curve from time zero to 24 h),'}, {'measure': 'Pharmacokinetics parameter AUC', 'timeFrame': 'From start to end of assessment', 'description': 'AUCinf (the area under the plasma concentration-time curve from time zero extrapolated to infinity, if feasible)'}, {'measure': 'Pharmacokinetics parameter elimination', 'timeFrame': 'From start to end of assessment', 'description': 'elimination constant λz and t½ (terminal elimination half-life, if feasible), and systemic plasma clearance (Cl) and volume of distribution (Vd)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues', 'Tolerance']}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy male and female subjects, body mass index (BMI) 18-28 kg/m2, body weight from 50 kg (females) or 60 kg (males) up to 100 kg, good general health.\n\nExclusion Criteria:\n\n\\- History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Febrile convulsions in childhood do not necessarily exclude a subject, but subjects with any type of generalized seizure in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.'}, 'identificationModule': {'nctId': 'NCT04689035', 'briefTitle': 'A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avilex Pharma'}, 'officialTitle': 'A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144', 'orgStudyIdInfo': {'id': 'AVLX-144CS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'AVLX-144\\_dose1', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'AVLX-144\\_dose2', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'AVLX-144\\_dose3', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'AVLX-144\\_dose4', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'AVLX-144\\_dose5', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': 'AVLX-144\\_elderly', 'interventionNames': ['Drug: AVLX-144', 'Drug: Placebo']}], 'interventions': [{'name': 'AVLX-144', 'type': 'DRUG', 'otherNames': ['Test drug'], 'description': 'Test drug', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Turku', 'country': 'Finland', 'facility': 'Clinical Research Services Turku / CRST Oy', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Mika Scheinin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Services Turku - CRST Oy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avilex Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}