Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01165502
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2010-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2010-07-16', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies)', 'timeFrame': 'Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic samples for CM3.1-AC100', 'timeFrame': 'Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7', 'description': 'Pharmacokinetics:\n\nFollowing the first dosing on Day 1:\n\nAUC, AUC0-t, AUC0-9h, Cmax, tmax, t1/2λz, λz, CL/F, Vz/F of CM3.1-AC100.\n\nFollowing multiple dosing on Day 7:\n\nAUCss, AUCss,0-t, AUCss,0-9h, Css,max, Css, min, tss,max, t1/2λz,ss, λz,ss, CLss/F, Vz,ss/F, of CM3.1-AC100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MAD study CM3.1-AC100', 'Healthy men, age 18 - 50'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent prior to any study specific procedures;\n* Male volunteer aged 18 to 50 years at Screening, both inclusive;\n* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)\n\nExclusion Criteria:\n\n* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;\n* Blood donation within 3 month before administration of the IP;\n* Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician'}, 'identificationModule': {'nctId': 'NCT01165502', 'briefTitle': 'Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'CellMed AG, a subsidiary of BTG plc.'}, 'officialTitle': 'Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'CellMed CM3.1-AC100/02'}, 'secondaryIdInfos': [{'id': '2010-020512-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CM3.1-AC100', 'description': 'Compound CM3.1-AC100 s.c.', 'interventionNames': ['Drug: CM3.1-AC100']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for compound CM3.1-AC100 s.c.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CM3.1-AC100', 'type': 'DRUG', 'description': 'MAD study with repeated subcutaneous (sc) doses', 'armGroupLabels': ['CM3.1-AC100']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for compound CM3.1-AC100 s.c.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Parexel International GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Peter Geigle, Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'CellMed AG, a subsidiary of BTG plc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellMed AG, a subsidiary of BTG plc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Peter Geigle', 'oldOrganization': 'CellMed AG'}}}}