Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT03103451
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-14', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration of BCD-121 After Single Subcutaneous Injection', 'timeFrame': '90 days'}, {'measure': 'Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection', 'timeFrame': '90 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers.', 'detailedDescription': 'Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-121 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* singed informed consent\n* male gender\n* 18-45 years of age inclusively\n* BMI between18.5-30.0 kg/sq.m.\n* absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis\n* parameters of complete blood count, blood biochemistry, and urinalysis do not exceed reference values, which are used at Study site laboratory\n* normal hemodynamic parameters\n* absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation\n* absence of infections within 4 weeks before randomization\n* absence of mental disorders or other conditions (incl. depression), which may affect the ability of participant to follow Protocol\n* health well-being (by volunteer's opining opinion) for at least 30 days before randomization.\n* absence of alcohol or drug addiction signs (incl. history of such addiction)\n* volunteer's ability to follow Protocol procedures\n* consent of volunteers and their sexual partners with childbearing potential to use adequate contraception\n\nExclusion Criteria:\n\n* history of use of monoclonal antibodies against IL-17 or TNFa\n* known severe allergy (anaphylaxis or multidrug intolerance)\n* known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-121/placebo\n* major surgery within 30 days prior screening\n* severe infections (required hospitalization, parenteral use of antimicrobial agents)\n* systemic use of antimicrobials\n* more than 4 episodes of respiratory tract infections within 6 months prior the screening\n* presence of any disorders which may affect pharmacokinetics of BCD-121\n* history of fever which was equal or exceeded 40 degrees in Celsius\n* history of hepatic transaminases increase 2.5 x ULN\n* history of seizures\n* actual or prior depression, suicidal tendencies\n* use of any medicines, vitamins, biologically active additives within 14 days prior the date of BCD-085 injection\n* use of any medicines which affects hemodynamics or hepatic function within 30 days prior the date of BCD-121 injection\n* simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation.\n* previous participation in this study"}, 'identificationModule': {'nctId': 'NCT03103451', 'briefTitle': 'First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'A Comparative Randomized Single-Blind Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Single Escalating Subcutaneous Doses of BCD 121 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BCD-121-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'This cohort includes 3 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7', 'description': 'This cohort includes up to 6 subjects in BCD-121 group and 1 subject in placebo group.\n\nIntervention: BCD-121/ placebo', 'interventionNames': ['Drug: BCD-121', 'Other: Placebo']}], 'interventions': [{'name': 'BCD-121', 'type': 'DRUG', 'otherNames': ['monoclonal bispecific antibody against human IL-17/ TNFa'], 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6', 'Cohort 7']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6', 'Cohort 7']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}