[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649928":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":35,"locations":43,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACT201 Injection group","EXPERIMENTAL",null,[13],"Drug: ACT201 Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"ACT201 Injection Placebo","PLACEBO_COMPARATOR",[18],"Drug: ACT201 Injection Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","ACT201 Injection","Part 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection per assigned dose group.\n\nPart 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"Part 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection administered per assigned dose group.\n\nPart 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection administered per assigned dose group; the treatment duration shall comply with the study protocol.",[15],[29,33],{"name":30,"affiliation":31,"role":32},"Jing Zhang, Ph.D.","Huashan Hospital","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":31,"role":32},"Wenhong Zhang, Ph.D.",[36,40],{"name":30,"role":37,"phone":38,"phoneExt":11,"email":39},"CONTACT","021-52887926","Zhangj_fudan@163.com",{"name":34,"role":37,"phone":41,"phoneExt":11,"email":42},"18121186602","zhangwenhong@fudan.edu.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":11,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Huashan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":52,"coordinates":53},"Point",[54,55],121.45806,31.22222,{"lat":55,"lon":54},[58,59],{"name":30,"role":37,"phone":38,"phoneExt":11,"email":39},{"name":34,"role":37,"phone":41,"phoneExt":11,"email":42},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[63],{"name":31,"class":64},"OTHER","100649928","phase-1-act201-injection-in-healthy-participants-and-participants-with-chronic-hepatitis-b-chb-100649928",false,"NCT07741461","ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)","A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, Drug Concentration-QTc Relationship, and Immunogenicity Profiles of Single and Multiple Doses of ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B","Inclusion Criteria:\n\nPart 1:\n\n* Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent;\n* Aged between 18 and 55 years old (inclusive) at the time of informed consent, male or female;\n* Body mass index meets specified criteria;\n* Physical examination, vital signs, laboratory tests, electrocardiogram and imaging examinations at screening are normal or abnormalities are considered clinically insignificant;\n* Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation.\n\nPart 2:\n\n* Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent;\n* Aged between 18 and 65 years old (inclusive) at the time of informed consent, male or female;\n* Body mass index meets specified criteria;\n* HBsAg-positive or HBV DNA-positive for at least 6 months, or previous liver biopsy confirming chronic HBV infection;\n* Receiving stable nucleos(t)ide analogue (NA) therapy at screening, with no planned changes to NA regimen during the trial;\n* Serum ALT ≤ 2 × ULN at screening; HBeAg, HBV DNA and HBsAg levels meet protocol-specified criteria;\n* Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation.\n\nExclusion Criteria:\n\nPart 1:\n\n* Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator).\n* History of clinically significant diseases involving cardiovascular, hematologic and lymphatic, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy).\n* Vital signs or laboratory examinations at screening meet the exclusion cut-off values specified in the protocol.\n* Use of any prescription drugs, over-the-counter medications, vitamin products or herbal medicines within 2 weeks prior to the first dose (topical medications with local effects are excluded).\n* Positive HBsAg, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening.\n* QTcF interval (QT corrected by Fridericia's formula) \\> 450 ms at screening.\n* Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening.\n* History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening.\n* History of alcohol abuse within 6 months before screening (14 alcohol units per week: 1 unit = 285 mL beer with \\~3.5% alcohol, or 25 mL spirits with \\~40% alcohol, or 100 mL wine with \\~10% alcohol), or positive breath alcohol test at screening.\n* Vaccination administered within 1 month before screening, or planned vaccination during the trial period.\n* Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period.\n* Female participants who are breastfeeding or have a positive serum pregnancy test at screening.\n* Participation in any clinical trial with an investigational medicinal product\u002Finvestigational device within 3 months before screening or within 5 half-lives (whichever is longer).\n* Any other condition deemed unsuitable for trial participation by the Investigator.\n\nPart 2：\n\n* Major trauma or major surgery within 3 months before screening; or planned surgery during the trial period that may impair trial compliance or safety assessment as assessed by the Investigator.\n* Uncontrolled and clinically significant abnormalities other than chronic HBV infection, such as acute cerebrovascular disease, severe or unstable cardiac disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled dyslipidemia, etc.\n* History of other clinically significant liver diseases.\n* History of liver cirrhosis or progressive liver fibrosis; or liver stiffness measurement (LSM) ≥ 8.5 kPa at screening.\n* Alpha-fetoprotein \\> 50 ng\u002FmL, or imaging suggestive of possible malignant hepatic lesions.\n* Past or current manifestations of hepatic decompensation.\n* History of extrahepatic diseases potentially related to HBV immune status.\n* History of vasculitis; or signs\u002Fsymptoms suggestive of underlying vasculitis; or past\u002Fcurrent other diseases potentially associated with vasculitic disorders.\n* Active infection requiring systemic antiviral or antibacterial treatment at screening, excluding HBV infection.\n* History of malignant tumors within 5 years before screening, except for specific curable cancers resected surgically.\n* Prior solid organ or bone marrow transplantation.\n* Use of systemic immunosuppressants within 3 months before the first dose of investigational product \\[short-term (≤7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune diseases excluded\\]; use of immunomodulators or cytotoxic agents within 6 months before the first dose of investigational product.\n* Receipt of any oligonucleotide or small interfering RNA (siRNA) therapy within 12 months before the first dose of investigational product.\n* Coexisting indication for anticoagulant therapy or anticipated requirement for anticoagulation during the trial.\n* Any of the following laboratory results at screening, or other clinically significant abnormalities rendering the participant unsuitable for trial participation:\n\nPlatelet count \\\u003C 125 × 10\\^9\u002FL Absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL Hemoglobin \\\u003C 100 g\u002FL Total bilirubin \\> 1.25 × ULN Serum albumin \\\u003C 35 g\u002FL Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the CKD-EPI formula) Prothrombin time international normalized ratio (INR) \\> 1.25 Positive hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody\n\n* QTcF interval (QT corrected by Fridericia's formula) \\> 450 ms at screening, or other clinically significant electrocardiogram abnormalities identified at screening.\n* Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator).\n* Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening.\n* History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening.\n* History of alcohol abuse within 6 months before screening, or positive breath alcohol test at screening.\n* Vaccination administered within 1 month before screening, or planned vaccination during the trial period.\n* Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period.\n* Female participants who are breastfeeding or have a positive serum pregnancy test at screening.\n* Participation in any clinical trial with an investigational medicinal product\u002Finvestigational device within 3 months before screening or within 5 half-lives (whichever is longer).\n* Any other condition deemed unsuitable for trial participation by the Investigator.",true,"ALL","18 Years","65 Years",{"count":77,"type":78},72,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy participants. Part 2 is a multiple ascending dose (MAD) trial enrolling HBeAg-negative chronic hepatitis B (CHB) participants with suppressed HBV DNA under stable nucleos(t)ide analog (NA) therapy.",[84],"Chronic Hepaititis B",[84,22],"2026-08-14",{"date":88,"type":89},"2026-08-17","ACTUAL",{"date":91,"type":89},"2026-08-06",{"date":93,"type":78},"2027-04",{"name":5,"class":6},1]