Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06657703
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 20 weeks'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Maximum Observed Concentration (Cmax) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Time to Reach Maximum Observed Concentration (Tmax) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Terminal Elimination Half-Life (t1/2) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Apparent Clearance (CL/F) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of HC022', 'timeFrame': 'Up to 20 weeks'}, {'measure': 'Number of Participants Who Develop Serum Anti-HC022 Antibodies', 'timeFrame': 'Up to 20 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects；To evaluate the immunogenicity of HC022 administered to healthy subjects.', 'detailedDescription': 'This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;\n2. Aged 18 to 55 years old, inclusive, male or female;\n3. 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg/m2)；\n4. Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；\n5. All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment；\n\nExclusion Criteria:\n\n1. Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is longer;\n2. History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for HBsAg or HBcAb or HBeAg)；\n3. History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；\n4. History of severe herpes infection or zoster viral infection；\n5. Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；\n6. History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；\n7. History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；\n8. Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；'}, 'identificationModule': {'nctId': 'NCT06657703', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'HC Biopharma Inc.'}, 'officialTitle': 'A Phase Ia Single Center, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Doses of HC022 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'HC022-I-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HC022 5mg SC', 'description': 'Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.', 'interventionNames': ['Drug: HC022', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HC022 50mg SC', 'description': 'Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.', 'interventionNames': ['Drug: HC022', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HC022 150mg SC', 'description': 'Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.', 'interventionNames': ['Drug: HC022', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HC022 450mg SC', 'description': 'Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.', 'interventionNames': ['Drug: HC022', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HC022 900mg SC', 'description': 'Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.', 'interventionNames': ['Drug: HC022', 'Drug: Placebo']}], 'interventions': [{'name': 'HC022', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['HC022 150mg SC', 'HC022 450mg SC', 'HC022 50mg SC', 'HC022 5mg SC', 'HC022 900mg SC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['HC022 150mg SC', 'HC022 450mg SC', 'HC022 50mg SC', 'HC022 5mg SC', 'HC022 900mg SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohong Han, PhD', 'role': 'CONTACT', 'email': 'hanxiaohong@pumch.cn', 'phone': '8613810659230'}, {'name': 'XiaoHong Han, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaohong Han', 'role': 'CONTACT', 'email': 'hanxiaohong@pumch.cn', 'phone': '86+13810659230'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaohong Han', 'role': 'CONTACT', 'email': 'hanxiaohong@pumch.cn', 'phone': '86+13810659230'}], 'facility': 'The Clinical Pharmacology Research Center of PUMCH', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Langxi Zhang, PhD', 'role': 'CONTACT', 'email': 'langxi.zhang@btyy.com', 'phone': '8602150433368'}, {'name': 'The Clinical Pharmacology Research Center of PUMCH', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HC Biopharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}