[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hangzhou PhecdaMed Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100638563","phase-2-clinical-study-of-tj0113-capsule-in-the-treatment-of-patients-with-sarcopenia-100638563",false,"NCT07620938","Clinical Study of TJ0113 Capsule in the Treatment of Patients With Sarcopenia","A Randomized, Double-Blind, Multicenter, Placebo Parallel-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of TJ0113 Capsule in the Treatment of Patients With Sarcopenia","Inclusion Criteria:\n\n1. Voluntarily participate in the clinical study and sign the informed consent form (ICF), willing and able to comply with the study protocol (e.g., able to understand and complete questionnaires, adhere to visit schedules, and use study medication);\n2. Male or female aged ≥60 years at the time of signing the ICF;\n3. Meet the diagnostic criteria of the \"Guideline for Diagnosis and Treatment of Sarcopenia in China (2024 Edition)\", specifically as follows:\n\n   3.1Low muscle mass: DXA measurement of muscle mass \\\u003C 7.0 kg\u002Fm2 in males \u002F \\\u003C 5.4 kg\u002Fm2 in females, or BIA measurement of muscle mass \\\u003C 7.0 kg\u002Fm2 in males \u002F \\\u003C 5.7 kg\u002Fm2 in females; 3.2Low muscle strength (grip strength \\\u003C 28.0 kg in males, grip strength \\\u003C 18.0 kg in females); and\u002For physical dysfunction (walking speed in free state \\\u003C 1 m\u002Fs, or 5 Times Sit-to-Stand Test ≥ 12 s, or Short Physical Performance Battery score ≤ 9).\n4. Able to complete the 400-meter Walk Test within 15 minutes without sitting down, leaning against a wall, requiring assistance from others, or using a walker or cane.\n5. Participants of childbearing potential (including spouses of male participants) must have no plans for pregnancy or sperm donation from the screening period until 6 months after the last dose, and must be willing to use at least one effective contraceptive method (see Appendix 1) for contraception.\n6. Results of comprehensive physical examination, vital signs, routine laboratory tests (hematology, blood biochemistry, urinalysis, coagulation), 12-lead ECG, chest X-ray, etc., are normal or, if abnormal, are judged by the investigator to be in the following condition: chronic diseases (e.g., hypertension, hyperlipidemia controlled within normal range, well-controlled non-insulin-dependent diabetes mellitus, etc.) that are judged by the investigator to be stably controlled, with regular medication according to a defined regimen for 4 weeks before screening, and that do not affect the study observation parameters after enrollment; abnormal screening test items judged by the investigator to be related to the participant's age or the aforementioned chronic diseases.\n\nExclusion Criteria:\n\n1. Presence of any medical condition that may interfere with adequate participation in the study, including but not limited to: history of epilepsy or complications, hemolytic anemia, pulmonary embolism or history of malignancy;\n2. Participants who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke (stroke), and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair\u002Freplacement; or those with severe arrhythmia as judged by the investigator at the time of screening;\n3. Personal or family history of long QT syndrome, family history of sudden death before the age of 40 in first-degree relatives (parents, children, and siblings); and\u002For personal history of unexplained syncope within 1 year prior to screening; and\u002For based on resting ECG results at screening: QT interval corrected for heart rate using Fridericia's formula, QTcF \\> 450 ms (males), QTcF \\> 470 ms (females) \\[Fridericia's formula: QTc = QT\u002F(RR0.33), where RR represents the standard heart rate value, calculated as 60 divided by heart rate\\];\n4. Presence of uncontrolled hypertension at screening, defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg (confirmed before randomization);\n5. Occurrence of chest pain, severe dyspnea, or other safety issues during baseline functional tests (e.g., 400-meter Walk Test);\n6. Presence of clinically significant hepatic impairment, defined as total bilirubin (TBIL) \\> 2 × upper limit of normal (ULN) or alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 2 × ULN;\n7. Presence of clinically significant renal impairment (creatinine clearance rate \\[Ccr\\] \\\u003C30 mL\u002Fmin). The formula for calculating Ccr is provided in Appendix II;\n8. Suffering from underlying diseases that may cause malnutrition, including chronic diarrhea (defined as a significant increase in bowel movement frequency compared to usual habits \\[\\>3 times\u002Fday\\], lasting \\>4 weeks, or recurrent diarrhea with intervals of 2-4 weeks), Crohn's disease and other digestive system diseases, neuropsychiatric disorders such as anorexia nervosa, uncontrolled diabetes mellitus (fasting blood glucose \\>8.3 mmol\u002FL after treatment) and other metabolic diseases, chronic obstructive pulmonary disease (Modified Medical Research Council Dyspnea Scale \\[MMRC\\] score ≥2), chronic heart failure (diagnosed according to the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, 2024, NYHA class III or above), and other chronic wasting diseases, which, in the investigator's judgment, make the patient unsuitable for participation in this study;\n9. Use of selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine, trazodone, citalopram, escitalopram, etc.) within 4 weeks prior to screening;\n10. Individuals with neuromuscular diseases (e.g., Parkinson's disease), or other muscle system disorders such as muscular atrophy or myositis that could affect the diagnostic parameters of sarcopenia;\n11. Individuals with a cardiac pacemaker or stent implanted in the body, or with metal internal fixation devices, excluding dentures;\n12. Individuals with physical disabilities or injuries\u002Fsurgeries to the upper or lower limbs within the past 3 months that could affect grip strength or gait speed measurements;\n13. Participants with a history of severe allergy, or known hypersensitivity\u002Fallergic reaction or intolerance to any component of the investigational product;\n14. Use of medications affecting musculoskeletal metabolism (bisphosphonates, estrogens, calcitonin, teriparatide, long-term oral or injectable corticosteroids) within 7 days or 5 half-lives before screening, whichever is longer (Note: Participants receiving a stable dose of denosumab for ≥ 6 months before screening and who will not change the dose during the study are allowed to enroll);\n15. Evidence of alcohol abuse (average weekly consumption of ≥ 14 units of alcohol, where 1 unit ≈ 360 mL of beer, or 45 mL of liquor, or 150 mL of wine) or alcohol dependence within 6 months before screening, which in the investigator's opinion would interfere with the participant's understanding or completion of the study;\n16. History of drug dependence\u002Fdrug abuse within the past 1 year;\n17. Positive for hepatitis B surface antigen (HBsAg) with HBV-DNA ≥ 1000 copies\u002FmL or 200 IU\u002FmL, or positive for hepatitis C virus (HCV) antibody with HCV RNA ≥ the lower limit of detection of the study site, or positive for human immunodeficiency virus (HIV) antibody, or positive for Treponema pallidum antibody at screening;\n18. Participation in a clinical study involving administration of an investigational drug, device, or surgery within 3 months or 5 half-lives (whichever is longer) before the first dose;\n19. Inability to swallow oral medications, or, in the investigator's judgment, presence of any condition that could significantly affect drug absorption, distribution, metabolism, or excretion (e.g., active enteropathy, partial or complete intestinal obstruction, chronic diarrhea), or any condition that could pose a risk to the participant;\n20. Participants who have a history of organ transplantation (excluding corneal transplantation);\n21. Blood donation (including blood products) or blood loss ≥ 400 mL, or receipt of blood transfusion (including blood products) within 1 month before screening;\n22. Pregnant or breastfeeding women;\n23. Other reasons deemed by the investigator that the participant has poor compliance or is unsuitable for participation in this study.","ALL","60 Years",{"count":19,"type":20},204,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, double-blind, multicenter, placebo parallel-controlled Phase II clinical study designed to evaluate the clinical efficacy and safety of TJ0113 Capsule in patients with sarcopenia. The entire study plans to enroll 204 participants with sarcopenia. Eligible participants will be stratified by age (\\\u003C 70 years or ≥ 70 years to ≤ 80 years or \\> 80 years) and block-randomized in a 1:1:1:1 ratio into 4 groups (TJ0113 Capsule 100 mg dose group; TJ0113 Capsule 200 mg dose group; TJ0113 Capsule 400 mg dose group; placebo group), with 51 participants per group. Participants in the placebo group will then be re-randomized in a 1:1:1 ratio to the respective dose groups (100 mg, 200 mg, and 400 mg). After randomization, study participants will receive continuous oral administration for 26 weeks with efficacy and safety evaluations, followed by a 1-week follow-up period after the end of treatment.",[26],"Sarcopenia","NOT_YET_RECRUITING","2026-05-27",{"date":30,"type":31},"2026-06-02","ACTUAL",{"date":33,"type":20},"2026-06-03",{"date":35,"type":20},"2027-10-22",{"name":37,"class":38},"Hangzhou PhecdaMed Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100594346","phase-2-clinical-trial-of-tj0113-capsules-in-the-treatment-of-patients-with-depressive-disorder-100594346","NCT07018245","Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder","A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-GroupClinical Trial to Evaluate the Safety and Efficacy of TJ0113 Capsules in Patients withDepressive Disorder","Inclusion Criteria:\n\n1. Subjects who voluntarily participates in the trial and signs the informed consent form (ICF);\n2. Male or female subjects, aged between 18 and 65 years (inclusive) at the time of signing ICF;\n3. Subjects whose HAMD-17 score ≥18 during the screening and baseline periods;\n4. Subjects who meet the diagnostic criteria for depressive disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), without psychotic symptoms;\n5. Subjects whose Clinical Global Impressions-Severity (CGI-S) scores ≥4 during the screening and baseline periods;\n6. Subjects who agree to discontinue the use of other antidepressants, anxiolytics, antipsychotics, mood stabilizers, benzodiazepine sedative-hypnotics, etc., except those specified in the study protocol during the treatment period; Subjects with reproductive potential (including spouses of male subjects) must have no plans for pregnancy or sperm donation from the screening period until 6 months after the last dose and must be willing to use at least one effective contraceptive method (such as abstinence, condoms, etc., as detailed in Section 5.3).\n\nExclusion Criteria:\n\n1. Presence of any medical condition that may interfere with the participation in the trial, including but not limited to the following: history of malignant tumors, history of epilepsy or complications, hemolytic anemia, pulmonary embolism, or respiratory depression;\n2. Within 6 months prior to screening, occurrence of congestive heart failure classified as New York Heart Association (NYHA) Class III or higher, unstable angina, acute myocardial infarction, hemorrhagic stroke (stroke), or ischemic stroke (including transient ischemic attack); or undergoing percutaneous coronary intervention, coronary artery bypass grafting, cardiac valve repair\u002Freplacement; or presence of severe arrhythmia as determined by the investigator at screening;\n3. A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and\u002For a personal history of unexplained syncope within 1 year prior to screening; and\u002For QTcF \\>450 ms (male) or QTcF \\>470 ms (female) based on resting ECG results at screening;\n4. Patients with uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg (checked prior to randomization);\n5. Subjects with clinically significant hepatic impairment, defined as total bilirubin (TBIL) \\>2× the upper limit of normal (ULN) or alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>2×ULN;\n6. Subjects with clinically significant renal impairment (creatinine clearance \\[Ccr\\] \\\u003C30 mL\u002Fmin). The Ccr calculation formula is provided in Note b.\n7. Subjects with history of any psychiatric disorders other than DSM-5 depressive disorder, including but not limited to: bipolar and related disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, schizophrenia, anxiety disorders, sleep-wake disorders, substance-related and addictive disorders, or depressive episodes secondary to other psychiatric or somatic conditions;\n8. Subjects whose HAMD-17 score at baseline shows a reduction ≥25% compared to the screening period.\n9. Subjects at risk of suicide: Those who have exhibited suicidal behavior (including actual attempts, interrupted attempts, or failed attempts) within 1 year prior to the first dose, or subjects with a score ≥3 on item 3 (SUICIDE) of the HAMD-17 scale at screening or baseline, or a 'yes' response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation, or subjects with a history of suicidal intent\u002Fself mutilation behavior during the current depressive episode;\n10. Subjects with history or current episode of failure to respond to two adequate courses of antidepressant treatment;\n11. Subjects who are receiving systemic psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other treatments during screening and\u002For at baseline, and who will continue to require these treatments during this study period;\n12. Subjects who have received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc., within 3 months prior to screening, or are considered by the investigator to currently require such treatment;\n13. Subjects who discontinued psychotropic medications less than 5 half-lives before randomization (at least 2 weeks for monoamine oxidase inhibitors and at least 4 weeks for fluoxetine);\n14. Subjects with history of severe allergies, or known hypersensitivity\u002Fallergic reaction or intolerance to any component of the investigational drug;\n15. Subjects with evidence of alcohol abuse (average weekly consumption ≥14 units of alcohol, where 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine) or alcohol dependence within the 6 months prior to screening, which the investigator considers may interfere with the subject's understanding or completion of the trial;\n16. Subjects with history of drug dependence\u002Fdrug abuse within the past 1 year;\n17. Subjects with history of hepatitis B, or positive hepatitis B virus surface antigen (HBsAg) at screening, or positive hepatitis C virus (HCV) antibody, or positive Human immunodeficiency virus (HIV) antibody, or positive treponema pallidum antibody;\n18. Subjects who participated in a clinical trial involving the administration of investigational drugs (new chemical entities), devices, or surgical procedures within 3 months or 5 half-lives (whichever is longer) prior to screening;\n19. Females with positive pregnancy test during screening or baseline visits, females who are pregnant, breastfeeding, or planning to become pregnant during the trial, or males or females of childbearing potential unwilling to use effective contraception within 6 months after the last dose;\n20. Subjects who are unable to swallow medications, or as judged by the investigator, have any condition that may significantly affect drug absorption, distribution, metabolism, and excretion (such as active intestinal disease, partial or complete intestinal obstruction, chronic diarrhea, etc.), or any condition that may pose a hazard to the participating subjects;\n21. Subjects with history of organ transplantation (excluding corneal transplantation);\n22. Subjects who donated blood or experienced blood loss ≥400 mL, or received blood transfusion within 3 months prior to screening;\n23. Subjects with poor compliance or other reasons that make the subject unsuitable for participation in this trial, as judged by the investigator.","18 Years","65 Years",{"count":50,"type":20},150,[23],"This study is a phase II, randomized, double-blind, multi-center, placebo-controlled, parallel-group clinical trial and 150 subjects with depressive disorder will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, subjects will be randomized in a 2:1 ratio to either the TJ0113 capsule group or the placebo group, with approximately 50 subjects receiving TJ0113 capsules and approximately 25 receiving placebo. Approximately 50 subjects will be enrolled in each of the TJ0113 capsule 200 mg group, TJ0113 capsule 400 mg group, and placebo group in this trial. Eligible subjects will be randomly assigned to receive continuous oral administration for 8 weeks, after which efficacy and safety will be evaluated, followed by an additional 1-week follow-up period after the end of treatment.",[54],"Depression","RECRUITING","2026-01-26",{"date":58,"type":31},"2026-01-28",{"date":60,"type":31},"2025-07-09",{"date":62,"type":20},"2026-09-01",{"name":37,"class":38},""]