[{"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:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,64,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651942","phase-1-a-study-to-evaluate-the-safety-tolerability-pk-and-preliminary-efficacy-of-hx15001-combined-with-etrasimod-in-moderate-severe-ulcerative-colitis-100651942",false,"NCT07768254","A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis","Evaluation of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HX15001 Injection Combined With Etrasimod Tablets in the Treatment of Moderate-severe Ulcerative Colitis: an Open-label, Exploratory Clinical Trial","Inclusion Criteria:\n\n* Patient able to read and understand, and willing to sign the informed consent form;\n* Weight≥40kg;\n* Clinical diagnosis of Ulcerative colitis (UC) that has been present for at least 3 years before the screening visit;\n* Mayo score of 5-9 at the baseline visits, including Mayo Endoscopic Score ≥2 and Rectal Bleeding Subscore ≥1, and disease extent from the anal verge ≥ 15 cm at screening.\n* Participants with a history of extensive colitis of ≥8 years' duration, or left-sided colitis of ≥10 years' duration, must have had a complete coloscopy within the past 1 year to exclude the presence fo dysplastic lesions.\n* Participants who have had an inadequate response to prior treatment with biologic agents or JAK inhibitors.\n* Willing and able to comply with clinic visits and study-related procedures.\n* Willing to use adequate birth control, if of reproductive potential and sexually active\n\nExclusion Criteria:\n\n* Evidence or history (within 6 months) of fulminant colitis, toxic megacolon, or intestinal perforation.\n* Prior colectomy (partial or total), or anticipated need for surgical intervention for UC during the study.\n* Prior or current diagnosis of Crohn's disease, fistulas\u002Fabscesses, indeterminate colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, active diverticulitis, or other colitis\u002Fenteritis that may confound efficacy assessment.\n* Current unresolved colonic dysplasia, adenoma, adenomatous polyps, or neoplastic lesions. Patients with history of adenomatous polyps are eligible if polyps were completely removed (documented) and screening colonoscopy\u002Fhistology shows no residual polyps or dysplasia.\n* Concomitant primary sclerosing cholangitis or autoimmune hepatitis.\n* Malignancy within 5 years prior to screening, except fully resected non-metastatic basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or papillary thyroid carcinoma with no recurrence.\n* Major surgery within 6 weeks prior to screening, or planned surgery during the study, unless judged not to increase patient risk or affect study compliance.\n* Any condition precluding endoscopic evaluation.\n* Unstable or poorly controlled cardiovascular (including atrial fibrillation requiring Class IA\u002FIII antiarrhythmics or QT-prolonging agents; unstable ischemic heart disease; Class I\u002FII heart failure; cardiac arrest; cerebrovascular disease; uncontrolled hypertension; symptomatic bradycardia; recurrent cardiogenic syncope; untreated severe sleep apnea; history of second-degree AV block without a functional pacemaker), respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurologic, or psychiatric disease that may compromise patient safety or confound efficacy assessment. - Patients requiring systemic corticosteroids for non-UC conditions (e.g., asthma, adrenal insufficiency, post-transplant) or with peripheral venous access issues are excluded.\n* Diabetes mellitus, uveitis, history of ocular surgery\u002Flaser, history of maculopathy, or active\u002Funcontrolled macular edema at screening.\n* Clinically significant 12-lead ECG abnormalities that may affect safety or interpretation, including QTcF \\>450 msec (males) or \\>470 msec (females), QRS \\>120 msec, or resting heart rate \\\u003C50 bpm (average of 3 measurements used for qualification).\n* Any of the following laboratory abnormalities:\n\n  1. Hemoglobin \\\u003C8.0 g\u002FdL\n  2. WBC \\\u003C2,500\u002Fmm³\n  3. Neutrophils \\\u003C1,000\u002Fmm³\n  4. Platelets \\\u003C100,000\u002Fmm³\n  5. Absolute lymphocyte count \\\u003C500\u002Fmm³\n  6. Serum creatinine \\>2× ULN\n  7. ALT or AST \\>2× ULN\n  8. Total bilirubin \\>1.5× ULN\n  9. Any other laboratory abnormality considered by the investigator to pose unacceptable risk.\n* History of alcohol, drug, or chemical abuse within 1 year prior to screening.\n* Receipt of live or live-attenuated vaccine within 3 months prior to Day 1, or planned during the study or within 5 weeks post-treatment. VZV antibody testing required for patients without documented history or complete vaccination; antibody-positive patients are eligible; antibody-negative patients may rescreen after complete VZV vaccination (≥4 weeks before etrasimod initiation).\n* Severe bacterial infection within 3 months (unless resolved with antibiotics), or chronic bacterial infection (e.g., pyelonephritis, osteomyelitis, bronchiectasis).\n* C. difficile infection within 30 days prior to Day 1 (may be retested once after 2 weeks of antibiotic therapy; persistent infection excludes enrollment).\n* Active invasive fungal infection (e.g., histoplasmosis) or parasitic infection.\n* Diagnosis of CMV colitis within 60 days (including screening period). CMV testing on colonic biopsy is required during screening only if clinically suspected.\n* Herpes zoster reactivation or CMV infection resolved within 2 months prior to screening.\n* Positive for HBsAg, or HBcAb positive with detectable HBV DNA; positive HCV antibody with detectable HCV RNA; positive Treponema pallidum antibody; or positive HIV antibody at screening.\n* Positive QuantiFERON-TB Gold or T-SPOT.TB test at screening.\n* Use of JAK inhibitors (e.g., tofacitinib, upadacitinib, filgotinib) within 4 weeks (or 5 half-lives, whichever is longer), or anti-TNF agents (e.g., adalimumab, infliximab), vedolizumab, or anti-IL-12\u002F23 agents (e.g., ustekinumab) within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.\n* Prior S1P receptor modulator therapy without a 3-month washout.\n* Use of investigational chemical drugs within 30 days, or investigational biologics within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.\n* IV corticosteroids within 2 weeks prior to Day 1 or planned during the study.\n* Corticosteroid enemas within 4 weeks, or corticosteroid suppositories and\u002For topical rectal 5-ASA within 2 weeks prior to Day 1, or planned during the study.\n* Topical (rectal) herbal enemas or suppositories within 1 week prior to Day 1 or planned during the study.\n* Immunosuppressants (e.g., tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, leflunomide, thalidomide) within 4 weeks (or 5 half-lives, whichever is longer) prior to Day 1 or planned during the study.\n* Immunoadsorption or fecal microbiota transplantation within 2 weeks prior to Day 1 or planned during the study.\n* NSAIDs (e.g., aspirin \\>100 mg\u002Fday) within 2 weeks prior to Day 1.\n* Immunoglobulin or blood products within 1 month prior to Day 1, or any condition likely to require such therapy during the study.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC).",[27],"Colitis, Ulcerative","NOT_YET_RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":21},"2026-09-09",{"date":36,"type":21},"2028-04-15",{"name":38,"class":39},"Helixon Biotechnology (Suzhou) Co., Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":40},"100627523","phase-1-phase-i-study-of-hxn6005-in-adult-healthy-participants-100627523","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,"55 Years",{"count":20,"type":21},[24],"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.",[54],"Healthy Volunteers (HV)","RECRUITING","2026-04-21",{"date":58,"type":32},"2026-04-24",{"date":60,"type":21},"2026-04-27",{"date":62,"type":21},"2027-03-13",{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"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":72,"type":21},28,[24],"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.",[76],"Atopic Dermatitis","2026-04-17",{"date":58,"type":32},{"date":80,"type":21},"2026-05-27",{"date":82,"type":21},"2027-04-16",{"name":38,"class":39},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":40},"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":92,"type":21},62,[24],"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.",[96],"Healthy Volunteers","2025-08-19",{"date":99,"type":32},"2025-08-24",{"date":101,"type":32},"2025-06-11",{"date":103,"type":21},"2026-09-30",{"name":38,"class":39},""]