Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06097702
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment emergent Adverse events (TEAEs)', 'timeFrame': 'SAD-Screening to Day 7; MAD- Screening to Day 14', 'description': "TEAE will be collected to assess participants' safety after BX-001N treatment"}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'SAD-Screening to Day 7; MAD- Screening to Day 14'}, {'measure': 'Number of participants with changes in the 12-lead electrocardiogram (ECG)', 'timeFrame': 'SAD-Screening to Day 7; MAD- Screening to Day 14'}, {'measure': 'Number of incidences of injection site reactions', 'timeFrame': 'SAD-Day 1 to Day 2; MAD- Day 1 to Day 5'}], 'secondaryOutcomes': [{'measure': 'Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD', 'timeFrame': 'SAD- Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': "SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing."}, {'measure': 'Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD', 'timeFrame': 'SAD- Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': "SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing."}, {'measure': 'Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD', 'timeFrame': 'SAD- Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': "SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 14 after dosing."}, {'measure': 'Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)', 'timeFrame': 'SAD-Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': 'Up to 3 samples will be collected in total and additional samples if positive results'}, {'measure': 'Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)', 'timeFrame': 'SAD-Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': 'Up to 3 samples will be collected in total and additional samples if positive results'}, {'measure': 'Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)', 'timeFrame': 'SAD-Day 1 to Day 7; MAD- Day 1 to Day 14', 'description': 'Up to 3 samples will be collected in total and additional samples if positive results'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemia-reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64 healthy participants', 'detailedDescription': 'This study comprises of 2 parts:\n\n* Part 1- Single Ascending Dose (SAD)- This part will enroll approximately 40 participants across 5 cohorts where each participant will receive a single intravenous (IV) bolus dose in healthy participants. On Day 1, participants in each cohort will receive investigational product (IP) (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.\n* Part 2 -Multiple Ascending Dose (MAD)- This part will enroll approximately 24 participants across 3 cohorts where each participants will receive intravenous (IV) bolus dose for 4 sequential daily. At the same time each morning from Day 1 to Day 4 (inclusive), participants in each cohort will receive IP (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 50 years of age\n* In good general health at Screening and/or before the first administration of IP\n* BMI \\> 18.0 and \\< 32.0 kg/m2 at Screening\n* Nonsmoker and must not have used any tobacco products within 2 months prior to screening\n* Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period\n* Person who can provide written informed consent prior to the commencement of all study procedures\n\nExclusion Criteria:\n\n* Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol\n* Genetic disorder with severe and abnormal bilirubin metabolism\n* Blood or plasma donation or significant blood loss prior to the first administration of IP\n* Viral or bacterial infection prior to the first administration of IP\n* Poor venous access\n* Significant scarring or tattoos at the planned site of IP administration\n* History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents\n* History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease\n* History of malignancy prior to Screening\n* Abnormal ECG findings\n* History or presence of a condition associated with significant immunosuppression\n* History of life-threatening infection\n* Infections requiring parenteral antibiotics\n* Vaccination prior to the first administration of IP\n* Exposure to any significantly immune suppressing drug\n* Abnormal vital signs findings\n* Abnormal laboratory findings\n* Positive results for viral testing at Screening\n* Positive result at Screening and Day -1 for toxicology screening panel\n* History of substance abuse or dependency or history of recreational intravenous (IV) drug use\n* Excess of regular alcohol consumption\n* Use of any IP or investigational medical device within 30 days prior to Screening\n* Unable to adhere to the prohibited therapies\n* Unwilling to adhere to the dietary restrictions\n* Unwilling to refrain from strenuous exercise'}, 'identificationModule': {'nctId': 'NCT06097702', 'briefTitle': 'A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bilix Co.,Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BX-001N After Intravenous Administration in Healthy Participants', 'orgStudyIdInfo': {'id': 'BX-001N-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BX-001N Part 1', 'description': 'Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.', 'interventionNames': ['Drug: BX-001N Part 1']}, {'type': 'EXPERIMENTAL', 'label': 'BX-001N Part 2', 'description': 'Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast.', 'interventionNames': ['Drug: BX-001N Part 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching doses of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BX-001N Part 1', 'type': 'DRUG', 'description': 'Dosage form- IV bolus Dosage- In the five cohorts, each participant receives a single IV bolus administration in one of the five doses based on body weight and followed up for 7 days.', 'armGroupLabels': ['BX-001N Part 1']}, {'name': 'BX-001N Part 2', 'type': 'DRUG', 'description': 'Dosage form- IV bolus Dosage- In the three cohorts, each participant receives a single IV bolus administration for 4 sequential days in one of the three doses based on body weight and followed up for 14 days.', 'armGroupLabels': ['BX-001N Part 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive matching placebo across Part 1 and 2 of the study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX Clinical Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Angela C Rowland, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMAX Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bilix Co.,Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}