Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-10 @ 11:20 PM
Study NCT ID:
NCT05274659
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AE', 'timeFrame': 'Day 1 through Day 14', 'description': 'An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 144 hours postdose', 'description': 'The maximum measured concentration of the analysis in serum'}, {'measure': 'Tmax', 'timeFrame': 'Up to 144 hours postdose', 'description': 'Time To Reach The Maximal serum Concentration'}, {'measure': 't½', 'timeFrame': 'Up to 144 hours postdose', 'description': 'Terminal Elimination Half-Life'}, {'measure': 'AUC0-inf', 'timeFrame': 'Up to 144 hours postdose', 'description': 'Area Under the Serum Concentration Versus Time Curve From Zero to Infinity'}, {'measure': 'IgG level', 'timeFrame': 'Day 1 through Day 63', 'description': 'Concentration of Immunoglobulin G in serum'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.', 'detailedDescription': 'This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 55 years, inclusive.\n2. Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively.\n3. Immunoglobulin (IgG) levels at screening is within the normal range.\n4. Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, biochemistry, and urinalysis.\n\nExclusion Criteria:\n\n1. History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency.\n2. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.\n3. Any clinically significant illness in the 28 days prior to the first study drug administration.\n4. Any history of tuberculosis.\n5. Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests.\n6. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration.\n7. Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent.\n8. Received an investigational drug (or was using an investigational device at the time) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer.\n9. Female who is lactating.\n10. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.'}, 'identificationModule': {'nctId': 'NCT05274659', 'briefTitle': 'A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Bao Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Randomized, Single-blinded, Placebo Controlled, Single Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of KJ103 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SHBJ-2021-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KJ103 dose group 1', 'description': 'KJ103 single dose', 'interventionNames': ['Drug: KJ103']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KJ103 dose group 2', 'description': 'KJ103 single dose', 'interventionNames': ['Drug: KJ103']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KJ103 dose group 3', 'description': 'KJ103 single dose', 'interventionNames': ['Drug: KJ103']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KJ103 dose group 4', 'description': 'KJ103 single dose', 'interventionNames': ['Drug: KJ103']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'KJ103 dose group 5', 'description': 'KJ103 single dose', 'interventionNames': ['Drug: KJ103']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo for each dose group', 'description': 'placebo, single dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KJ103', 'type': 'DRUG', 'otherNames': ['no other invention names'], 'description': 'Recombinant Immunoglobulin G Cleaving Enzyme', 'armGroupLabels': ['KJ103 dose group 1', 'KJ103 dose group 2', 'KJ103 dose group 3', 'KJ103 dose group 4', 'KJ103 dose group 5']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['no other invention names'], 'description': 'Placebo', 'armGroupLabels': ['Matching placebo for each dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Paul Hamilton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Zealand Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Bao Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}