[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Talengen Institute of Life Sciences, Shenzhen, P.R. China.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100571924","phase-1-tp04hn106-in-the-treatment-of-patients-with-amyotrophic-lateral-sclerosis-100571924",false,"NCT06726577","TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis","A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial Evaluating the Safety, Efficacy, and Pharmacokinetic Characteristics of TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;\n2. Age ≥18 years old, male or female;\n3. The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;\n4. Pre-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;\n5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. The subject is known to be allergic to the investigational drug or its excipients;\n2. The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease of the heart, lung, liver, or brain, or is accompanied by a failure of different organs (for patients with respiratory failure, only patients diagnosed as type I or type II respiratory failure are excluded);\n3. The subject has a major mental illness or cognitive dysfunction;\n4. Patients with a history of secondary or above surgery within one month before the screening period;\n5. The subjects participated in other clinical studies within 1 month;\n6. The subjects are pregnant or lactating women;\n7. Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.\n\n   \\-","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This trial adopts a multicenter, randomized, double-blind, placebo-controlled parallel design.\n\nThis experiment is divided into two groups: the experimental drug group and the placebo group. Successful participants will be randomly assigned to the two groups, with an expected enrollment of 60 participants. There will be 30 participants in the experimental drug group and 30 participants in the placebo group. During the treatment period, the experimental drug group received intravenous injections of 0.5mL\u002Fkg TP04HN106 each time; The placebo group received intravenous injections of 0.5mL\u002Fkg of saline each time. During the extension period, all subjects received intravenous injection of 0.5mL\u002Fkg TP04HN106. In the experiment, all subjects received Liraglutide tablets as the standard baseline treatment.\n\nThe subjects who were successfully screened in the experiment were enrolled in sequence, and the safety, tolerability, efficacy, and pharmacokinetic characteristics of the experimental drug were evaluated after administration. The entire trial includes a screening period of 1 week, a treatment period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), an extension period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), and a follow-up period of 4 weeks. In addition, some subjects underwent a 1-week single dose PK study before the start of the treatment period; In addition, during the first treatment cycle of the treatment period, some subjects were selected for multiple dosing PK studies.\n\nWe plan to conduct a single dose PK study among 12 subjects, with 6 subjects in the experimental group and 6 subjects in the control group; Multiple dose PK studies were conducted among 12 subjects, with 6 subjects in the experimental group and 6 sujects in the control group. It is not allowed for the same subject to participate in both single dose and multiple dose PK studies simultaneously.\n\nThe 1st to 12th subjects planned to be enrolled in the trial will undergo a single dose PK study. After the first dose, venous blood will be collected from the 12 subjects according to the blood sample collection requirements, and their PK characteristics will be evaluated. The observation period for single dose administration is one week. After completing the final blood sample collection and safety assessment, the subjects enter the treatment period, extension period, and follow-up period.\n\nThe 13th to 24th subjects planned to be enrolled in the trial will undergo multiple dose PK studies. These 12 subjects will have their venous blood collected according to the blood sample collection requirements during the first treatment cycle of the treatment period, and their PK characteristics will be evaluated. After completing the treatment period, the subjects will enter the extension period and follow-up period.",[27],"Amyotrophic Lateral Sclerosis","RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":20},"2026-05-10",{"date":36,"type":20},"2027-04",{"name":38,"class":39},"Talengen Institute of Life Sciences, Shenzhen, P.R. China.","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100553192","phase-2-tp03hn106-in-patients-with-critical-limb-ischemia-100553192","NCT06482892","TP03HN106 in Patients With Critical Limb Ischemia","A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia","Inclusion Criteria:\n\n1. When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender;\n2. Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6.\n3. Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week);\n4. During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery;\n5. During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb rest pain caused by lower limb ischemia, with a disease duration of ≥ 2 weeks, and a VAS score of ≥ 40mm and \\\u003C 100mm before the first administration; There are limb tissue ulcers caused by lower limb ischemia, with a disease duration of ≥ 2 weeks and limb ulcers (4cm2 ≤ maximum single ulcer area ≤ 25cm2);\n6. All subjects with fertility or their spouses must take effective contraceptive measures within 3 months after signing the informed consent form until the completion of the trial;\n7. The subjects voluntarily give informed consent and sign an informed consent form (if the subjects and\u002For their guardians lack reading ability and cannot understand the content of the informed consent, they need to sign together with a fair witness), fully understand the methods and procedures of the experiment, and be able to provide biological samples for testing related indicators in accordance with the experiment requirements.\n\nExclusion Criteria:\n\n1. Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products;\n2. Patients with limb gangrene greater than 4 cm2;\n3. Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured);\n4. Screening period for patients with liver and kidney failure:\n5. Patients who require hemodialysis;\n6. Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form;\n7. During the screening period, subjects with mental illness, obvious mental disorders or epilepsy, including other individuals with no behavioral or cognitive abilities;\n8. Hypertensive patients (SBP ≥ 160mmHg and\u002For DBP ≥ 100mmHg) who cannot be controlled after standardized treatment in the screening period;\n9. Individuals who have received fresh plasma, cold precipitates, or blood products containing TP03HN106 components within one month prior to signing the informed consent form;\n10. Those who have participated in clinical trials of other drugs or medical devices within one month before signing the informed consent form;\n11. Those who have undergone or plan to undergo surgery during the trial period within one month prior to signing the informed consent form;\n12. Alcoholism and\u002For psychoactive substances, drug abusers and dependents (alcoholism standard: the weekly alcohol intake is more than 21 units (male) and 14 units (female) (1 unit=360 mL beer; or 150 mL wine; or 45 mL white spirit);\n13. Miscarriage or termination of pregnancy less than 3 months prior to signing the informed consent form, pregnant women and lactating women (currently breastfeeding or not artificially breastfeeding but less than 6 months after delivery);\n14. Poor compliance or any other situation that the researcher deems unsuitable for inclusion.",{"count":49,"type":20},15,[24],"Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.",[53],"Critical Limb Ischemia","2025-04-10",{"date":56,"type":32},"2025-04-15",{"date":58,"type":32},"2024-07-18",{"date":60,"type":20},"2025-12-30",{"name":38,"class":39},""]