Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-07 @ 12:36 PM
Study NCT ID:
NCT05984368
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2023-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of BG136 Injection in Healthy Chinese Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single-dose and multi-dose, dose escalation, placebo-controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-27', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'up to 14 days', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'up to 14 days', 'description': 'Evaluation of Peak Plasma Concentration (Cmax)'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)0-t', 'timeFrame': 'up to 14 days', 'description': 'Evaluation of Area under the plasma concentration versus time curve (AUC)0-t'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)0-∞', 'timeFrame': 'up to 14 days', 'description': 'Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)', 'detailedDescription': 'This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD) study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all receiving the test drug), and eight subjects enrolled in each of the remaining groups (six test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose groups: two subjects (six test drug and two placebo); and Part III: a randomized, double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized, double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each including 8 healthy subjects (6 test drug, 2 placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chinese male or female subjects aged 18-55 years (including the threshold);\n* Weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI): 19.0-26.0 kg/m2 (including borderline values);\n* Subjects understand and comply with the study process, can communicate well with the investigator, volunteer to participate in the trial and sign an informed consent form.\n\nExclusion Criteria:\n\n* Diseases to be excluded due to clinical abnormalities within 3 months prior to screening, including but not limited to neurological/psychiatric, cardiovascular, hematological and lymphatic, immune, gastrointestinal, urinary, endocrine, metabolic, and skeletal conditions. History of diseases of the urinary, endocrine, respiratory, metabolic and skeletal systems.\n* History of comorbid gastrointestinal related disorders\n* Those who have had surgery within 3 months prior to screening or plan to have surgery during the study period；\n* Screening subjects whose vital signs, physical examination, routine blood, urine, blood biochemistry, coagulation function, and electrocardiogram are judged by the investigator to be abnormal and clinically significant；\n* Subject's imaging determined by the investigator to be clinically significant for abnormalities；\n* Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody screening, human immunodeficiency virus (HIV) antibody screening, treponema pallidum antibody (TP-Ab) any test positive；\n* History of food or drug allergies or other allergic diseases；\n* History of substance abuse in the 12 months prior to screening, or drug use in the 3 months prior to screening, or a positive urine drug screen；\n* Positive breath test results for alcohol or regular alcohol consumption in the 6 months prior to screening, i.e., an average of more than 14 units of alcohol per week (1 unit ≈ 200 mL of beer at 5% alcohol or 25 mL of spirits at 40% alcohol or 85 mL of wine at 12% alcohol), or inability to abstain from alcohol consumption for 48 hours prior to the first dose of the medication and for the entire study period；\n* Smokers who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening or who could not give up smoking 48 hours prior to the first dose and throughout the study period；\n* Those who have received a blood transfusion or used blood products ≥ 400 mL or 2 units within 3 months prior to screening, or those who have lost ≥ 400 mL of blood within 6 months, or those who have donated blood within 3 months；\n* Participated in another clinical trial within 3 months prior to screening and took the trial drug or used the trial device；\n* Any prescription (including vaccines), over-the-counter medications used within 4 weeks prior to screening；\n* Those who have used herbal medicines or health supplements for the treatment and/or prevention of their own disease within 2 weeks prior to screening；\n* Persons with special dietary requirements who are unable to follow a standardized diet or who are unable to avoid xanthine-rich beverages or foods or fruits or fruit juices that may interfere with metabolism for 48 hours prior to dosing and up to study completion;\n* Those who have difficulty in collecting blood from veins or who suffer from needle;\n* Women who are pregnant, breastfeeding, or who have had unprotected sex within 2 weeks prior to screening, or who have had a positive pre-test pregnancy test;\n* Male subjects (or their partners) or female subjects who are planning a pregnancy, sperm donation, or oocyte donation from the time of signing the Informed Consent Form until 3 months after the end of the administration of the medication;\n* Those who do not wish to use one of the medically approved non-pharmacological contraceptives (e.g., intrauterine device or condom) during the trial period;\n* Subjects deemed unsuitable by the investigator to participate in the study."}, 'identificationModule': {'nctId': 'NCT05984368', 'briefTitle': 'A Clinical Study of BG136 Injection in Healthy Chinese Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation and Multiple Dose Escalation Phase I Clinical Trial of BG136 for Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BG136211213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo).', 'interventionNames': ['Drug: BG136', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo).', 'interventionNames': ['Drug: BG136', 'Drug: Placebo']}], 'interventions': [{'name': 'BG136', 'type': 'DRUG', 'description': 'Subjects injected with BG136 in Part 1 and Part 2', 'armGroupLabels': ['Part 1', 'Part 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects injected with Placebo in Part 1 and Part 2', 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Cao, Dr', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '86-18661809090'}], 'facility': 'Affiliated Hospital of Qingdao University Phase I Clinical Research Center', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Yu Cao, doctor', 'role': 'CONTACT', 'email': 'caoyu1767@126.com', 'phone': '86-18661809090'}], 'overallOfficials': [{'name': 'Yu Cao, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Qingdao University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Trials Center of Affiliated Hospital of Qingdao University', 'investigatorFullName': 'Cao Yu', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}