Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT03224702
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-30', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)', 'timeFrame': 'Baseline up to Day 75'}, {'measure': 'Occurrence of TEAEs and SAEs by Severity', 'timeFrame': 'Baseline up to Day 75'}, {'measure': 'Number of Subjects With Injection Site Reactions (ISRs)', 'timeFrame': 'Baseline up to Day 75'}, {'measure': 'Number of Subjects with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline up to Day 75'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to the Last Sampling Time (t) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Apparent Terminal Half-Life (t1/2) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Apparent Terminal Rate Constant (λz) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Apparent Body Clearance (CL/F) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Apparent Volume of Distribution During the Terminal Phase (Vz/F) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Percent Change From Baseline in Serum Aggrecan Degradation neo-Epitope (ARGS) at Day 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 22, 29, 39, 49, 61 and 75', 'timeFrame': 'Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 22, 29, 39, 49, 61 and 75'}, {'measure': 'Number of Subjects With Anti-drug Antibodies (ADA) for M6495', 'timeFrame': 'Pre-dose, Day 8, 22, 49 and 75'}, {'measure': 'Levels of Anti-Drug Antibodies (ADA) Titers', 'timeFrame': 'Pre-dose, Day 8, 22, 49 and 75'}, {'measure': 'Change From Baseline in Telemetry Electrocardiogram (ECG) Intervals Up to 24 hours post Day 1 dose', 'timeFrame': 'Baseline, Up to 24 hours post Day 1 dose'}, {'measure': 'Slope of Exposure vs QTc From Digital Electrocardiogram Triplicates', 'timeFrame': 'Baseline up to Day 75'}, {'measure': 'Maximal Effect (Imax) of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}, {'measure': 'Inhibitory Concentration (IC) 10, IC50 and IC90 of M6495', 'timeFrame': 'Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['M6495', 'anti-A disintegrin and metalloproteinase with thrombospondin motifs-5 nanobody', 'Osteoarthritis'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This First-In-Human trial will be conducted in healthy male subjects to explore the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of M6495.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Body Mass Index (BMI) of greater than or equal to (\\>=) 18.5 and less than or equal to (=\\<) 29.9 Kilogram per square meter (kg/m\\^2), and a body weight between 50 and 100 kg at screening.\n* Subjects must agree to use effective method(s) of contraception during the trial.\n* Other protocol defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Subjects who have recently participated in other clinical trials.\n* Donated blood, have a significant medical condition, history of drug hypersensitivity, consumption of large amounts of xanthine-containing foods or beverages, recent or ongoing concomitant medication, hypertension, tachycardia and significant findings on electrocardiogram\n* Positive drug screening test, positive test for Hepatitis B or C or human immune deficiency virus (HIV), or have been kept in detention\n* Other protocol defined exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT03224702', 'briefTitle': 'First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Single-Center, Phase I, Randomized, Double Blind, Placebo-Controlled, First-In-Human Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous Injected M6495 (Anti-ADAMTS-5 Nanobody) in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'MS200572-0009'}, 'secondaryIdInfos': [{'id': '2017-001663-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M6495', 'interventionNames': ['Drug: M6495']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'M6495', 'type': 'DRUG', 'description': 'Subjects will receive M6495 on Day 1', 'armGroupLabels': ['M6495']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive placebo matched to M6495 on Day 1', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'DanTrials ApS c/o Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}