[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Helixon Biotechnology (Suzhou) Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627523","phase-1-phase-i-study-of-hxn6005-in-adult-healthy-participants-100627523",false,"NCT07449741","Phase I Study of HXN6005 in Adult Healthy Participants","A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HXN6005 in Healthy Participants","Inclusion Criteria:\n\n1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.\n2. Male and female participants aged between 18 to 55 years, inclusive.\n3. Participants must have a body mass index between 18 to 35 kg\u002Fm2, inclusive.\n4. Healthy participants, in the opinion of the Investigator and as determined by medical history, with normal or clinically acceptable physical examination, clinical laboratory tests and ECG results at Screening and before randomization.\n5. Female participants must be postmenopausal, surgically sterile, or, if of childbearing potential, agree to use highly effective contraception combined with a condom from screening until 180 days post-dose, and refrain from egg donation or in vitro fertilization during this period.\n6. Male participants, with their female partner of childbearing potential, agree to use a condom as well as highly effective contraception, and refrain from sperm donation and in vitro fertilization until 180 days after the dosing of the study drug.\n7. Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.\n\nExclusion Criteria:\n\n1. Females who are pregnant, planning to become pregnant, or lactating during the trial;\n2. History of febrile illness or evidence of any active or suspected infection within 30 days before randomization;\n3. Participant at risk for tuberculosis;\n4. History of malignancy within 5 years before randomization, except for non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been successfully treated\u002Fexcised for more than 12 months;\n5. Have known type I\u002FII diabetes;\n6. Positive for human immunodeficiency virus antibodies, syphilis antibodies, hepatitis B surface antigen, or hepatitis C antibodies;\n7. Positive for drugs use before randomization;\n8. Have used nicotine or tobacco containing products within 3 months prior to dosing, or unwilling to abstain from the use of tobacco or nicotine containing products during confinement in the CRU;\n9. Have a history of alcohol abuse (alcohol consumption in excess of 14 units per week (1 unit contains 14g alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) in the past one year before randomization, or unwilling to abstain from alcohol for 48 hours prior to admission to the CRU;\n10. Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives before randomization, or plan to receive another experimental agent during the trial;\n11. Known exposure to any type of antibody or anti-TSLP therapy within 5 half-lives before randomization;\n12. Have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days before randomization, or those who plan to donate blood during the trial or within 30 days after the end of the study;\n13. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) before randomization;\n14. Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID\u002Fflu) within 2 weeks before randomization, or plan to receive vaccines during the trial;\n15. Participants with herpes zoster reactivation or cytomegalovirus that resolved within 60 days before randomization;\n16. Have clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months before randomization, or plan to have any surgeries during the trial;\n17. History of clinically significant hypersensitivity reactions to biologic agents, therapeutic proteins, or to specific excipients relevant to the study drug formulation.\n18. Have any other conditions that would, in the opinion of the investigator, put the participants at increased risk for participation in this trial.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants.\n\nResearchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug).\n\nParticipants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.",[28],"Healthy Volunteers (HV)","RECRUITING","2026-04-21",{"date":32,"type":33},"2026-04-24","ACTUAL",{"date":35,"type":22},"2026-04-27",{"date":37,"type":22},"2027-03-13",{"name":39,"class":40},"Helixon Biotechnology (Suzhou) Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100635212","phase-1-a-dose-escalation-phase-1-study-of-hxn5003-in-healthy-participants-100635212","NCT07549750","A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants","A Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics of HXN5003 in Healthy Participants","Inclusion Criteria:\n\n1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.\n2. Male and female participants aged between 18 to 55 years, inclusive.\n3. Participants must have a body mass index between 18 to 32 kg\u002Fm2, inclusive.\n4. Able to participate and comply with all study procedures and restrictions\n5. Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.\n\nExclusion Criteria:\n\n1. Females who are pregnant, planning to become pregnant, or lactating during the trial.\n2. Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization;\n3. Participant who has known positive tuberculin skin test or recent exposure to an individual with active tuberculosis (TB), or current clinical or laboratory evidence of active TB.\n4. Participant who has history of malignancy within 5 years before randomization, excluding localized basal cell carcinoma or cutaneous squamous cell carcinoma of the skin that have been resected or cured..\n5. Participant who has known type I\u002FII diabetes.\n6. Positive for human immunodeficiency virus (HIV) antibodies, syphilis test, hepatitis B surface antigen, or hepatitis C antibodies.\n7. Participant who has tested positive for drugs use at Screening or before randomization;\n8. Participant who has used nicotine or tobacco containing products within 3 months (\\>5 cigarettes or an equivalent amount of tobacco per day)\n9. Participant who has a history of alcohol abuse (alcohol consumption in excess of 14 units per week\n10. Participant who has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;\n11. Participants who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing.\n12. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing;\n13. Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID\u002Fflu) within 2 weeks prior to randomization,\n14. Participants with herpes zoster reactivation or cytomegalovirus (CMV) that resolved less than 60 days prior to signing informed consent.\n15. Abnormal renal function estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C 70mL\u002Fmin\u002F1.73m2\n16. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results\n17. Participant who has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to randomization, or plan to have any surgeries during the duration the trial;\n18. History of any severe hypersensitivity or allergic reaction (i.e. anaphylaxis or angioedema) to any drug;\n19. History of, or current, clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurologic, psychiatric, immunologic, Gilbert's Syndrome and allergic disease or any other condition, in the opinion of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the participant at risk in this study or interfere with the interpretation of data.\n20. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.",{"count":50,"type":22},28,[25],"The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are:\n\n1. Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles?\n2. Will immunogenicity of HXN5003 in healthy participants be altered? This study will be compared against a Placebo which contains the same inactive ingredients as those of HXN5003, but without the active ingredient.",[54],"Atopic Dermatitis","NOT_YET_RECRUITING","2026-04-17",{"date":32,"type":33},{"date":59,"type":22},"2026-05-27",{"date":61,"type":22},"2027-04-16",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":41},"100592921","phase-1-study-of-hx15001-in-adult-healthy-volunteers-100592921","NCT06999720","Study of HX15001 in Adult Healthy Volunteers.","A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.","Inclusion Criteria:\n\n1. An informed consent document signed and dated by the subject.\n2. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.\n3. Have a Body mass index (BMI) of 18-32 kg\u002Fm2 , inclusive; with body weight ≥50 kg during the screening.\n4. In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.\n5. Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.\n\nExclusion Criteria:\n\n1. Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.\n2. Has a positive result of pregnancy test at Screening or Baseline\n3. History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis\n4. Subjects at risk for tuberculosis (TB).\n5. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;\n6. Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;\n7. Subjects who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing, or those who plan to donate blood during the study period or within 30 days after the end of the study;\n8. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing\n9. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results\n10. Has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to dosing, or plan to have any surgeries during the duration the trial.\n11. History of any hypersensitivity or allergic reaction to drugs;\n12. Has any other conditions that would, in the opinion of the investigator, put the subjects at increased risk for participation in this trial",{"count":71,"type":22},62,[25],"This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants.\n\nThe study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9).\n\nThe primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.",[75],"Healthy Volunteers","2025-08-19",{"date":78,"type":33},"2025-08-24",{"date":80,"type":33},"2025-06-11",{"date":82,"type":22},"2026-09-30",{"name":39,"class":40},""]