[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Siran Biotechnology Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100629837","phase-1-a-study-of-sa030-injection-in-overweight-or-obese-participants-100629837",false,"NCT07479862","A Study of SA030 Injection in Overweight or Obese Participants","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SA030 Injection in Overweight or Obese Participants","Inclusion Criteria:\n\n* You must be able to understand the study and sign a written consent form.\n* Men or women aged 18 to 55 years can join\n* Overweight or obese with a body mass index (BMI) between 25-40 kg\u002Fm\\^2(inclusive);\n* You should be generally healthy, The study doctor will check your medical history, vital signs, physical exam, blood and urine tests, Electrocardiogram, and abdominal. ultrasound. Minor issues are okay if the doctor thinks they are not medically important.\n* For female participants of childbearing potential: must be non-pregnant and non- lactating, and agree to use highly effective contraception throughout the study period;\n* For male participants of reproductive potential: must agree to use highly effective contraception during the study period to ensure effective contraception for sexual partners.\n\nExclusion Criteria:\n\n* You cannot join if you have lost or gained more than 5 percent of your body weight in the last 3 months.\n* You cannot participate if you previously had, or plan to have, weight-loss surgery or a weight-loss device during the study, except for the following procedures done more than 1 year before screening\n* Use of any over-the-counter medications, herbal supplements, or health products that may significantly affect weight or metabolism within 1 month prior to screening (e.g., orlistat, garcinia cambogia, ephedrine, etc.)\n* At screening, sitting systolic blood pressure more than of equals to 160 milli meters of mercury and\u002For diastolic blood pressure more than of equals to 100 mmHg, and deemed unsuitable for participation in this study by the investigator;\n* Severe psychiatric disorders or uncontrolled psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, or depression, deemed unsuitable for participation in this study by the investigator;\n* If the screening ECG shows a prolonged QT\u002FQTc interval, and a repeat test confirms QTcF greater than 450 ms in males or greater than 470 ms in females, the participant will be excluded\n* Suffering from severe diseases, including but not limited to disorders of the nervous system, cardiovascular system, hematopoietic and lymphatic system, immune system, digestive system, urinary system, respiratory system, endocrine system, and history of malignancies, which the investigator judges may compromise safety or influence study results;\n* Co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis; or prior diagnosis of hepatitis A, D, or E without resolution;\n* Individuals who received a vaccine or live attenuated vaccine within 1 month prior to dosing, or who plan to receive a vaccine during the trial period; Major surgery within 6 months prior to screening, or planned surgery during the study period;\n* Severe infection or trauma within 4 weeks prior to screening;\n* Non-physiological blood loss more than or equals 200 milliliter within 1 month prior to study drug administration (including trauma, blood collection, or blood donation), or individuals planning to donate blood during the study period or within 60 days after dosing;\n* History of severe intolerance to subcutaneous injections (mild reactions such as local swelling or redness are permissible);\n* Individuals who have taken any prescription medication, herbal supplements, or over-the-counter drugs within 14 days prior to study drug administration;\n* Participation in other drug clinical trials within 3 months of this study's treatment initiation, or within 5 half-lives of other investigational drug exposure, or participation in siRNA or antisense oligonucleotide drug clinical trials within 6 months prior to this study's treatment initiation (participants who withdrew from the study before receiving the investigational drug may be eligible for this study);\n* Individuals who smoked more than 5 cigarettes or an equivalent amount of tobacco daily within 3 months prior to screening, or who are unable to abstain from smoking during the trial hospitalization period;\n* Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit of alcohol ≈360 milli Liter beer or 45 milli Liter 40 percent alcohol spirits or 150 milli Liter wine), or those with a positive breath alcohol test on the day before dosing (breath alcohol content more than 0.0 milligram per100 mL), or those unable to abstain from alcohol during the trial hospitalization period;\n* Current or former drug users\u002Fsubstance abusers, or those with a positive urine drug screen on the day before dosing;\n* Other factors deemed unsuitable for trial participation by the investigator, such as potential for poor compliance.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is the first time SA030 is being given to people. The goal is to understand how safe it is, how well it is tolerated, and how the body processes and responds to a single dose of SA030 in individuals who are overweight or obese.\n\nOver the last few decades, more and more people around the world have become overweight or obese, and the numbers keep rising in almost every country. From 1990 to 2021, this problem grew steadily and reached its highest point in 2021.",[28,29],"Obese","Overweight",[31],"ALK7","NOT_YET_RECRUITING","2026-03-15",{"date":35,"type":36},"2026-03-18","ACTUAL",{"date":38,"type":22},"2026-04-16",{"date":40,"type":22},"2027-03-03",{"name":42,"class":43},"Suzhou Siran Biotechnology Co.,Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100614155","phase-1-sa1211-injection-phase-1-study-100614155","NCT07275918","SA1211 Injection Phase 1 Study","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Able to correctly understand and sign the informed consent form in writing.\n2. Male or female participants.\n\n   * For healthy participants: aged 18-55 years old (inclusive of the cut-off values).\n   * For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).\n3. Body Mass Index (BMI) meets the following requirements.\n\n   * For healthy participants: within the range of 18-28 kg\u002Fm² (inclusive of the cut-off values).\n   * For participants with chronic hepatitis B (CHB): within the range of 18-32 kg\u002Fm² (inclusive of the cut-off values).\n4. During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:\n\n   \\- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.\n5. For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and\u002For positive HBV deoxyribonucleic acid (HBV DNA).\n6. For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.\n7. For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.\n\nExclusion Criteria:\n\n1. Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.\n2. Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.\n3. Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.\n4. Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.\n5. Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.\n6. Participants with severe infection or trauma within 4 weeks before screening.\n7. Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.\n8. Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.\n9. Participants deemed unsuitable for the trial by the investigator due to other factors.","65 Years",{"count":54,"type":22},80,[25],"The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are:\n\nWhat are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)?\n\nParticipants will:\n\n* Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required.\n* Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.",[58],"Chronic Hepatitis B",[60],"CHB","RECRUITING","2025-12-08",{"date":64,"type":36},"2025-12-10",{"date":66,"type":36},"2025-11-25",{"date":68,"type":22},"2027-03-30",{"name":42,"class":43},""]