[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangxi Kvvit Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,68,90,111,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641312","phase-2-clinical-trial-of-dn022150-combined-with-ag-chemotherapy-as-first-line-treatment-for-locally-advanced-or-metastatic-pancreatic-cancer-with-kras-g12d-mutation-100641312",false,"NCT07656376","Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form\n2. Age 18-75 years (inclusive), male or female, at the time of signing informed consent\n3. Life expectancy ≥ 12 weeks\n4. Subjects with confirmed KRAS G12D who have not received prior systemic antineoplastic therapy for advanced or metastatic pancreatic cancer\n5. ECOG score of performance status 0 \\~ 1\n6. At least one measurable lesion by RECIST v1.1 criteria\n7. Adequate organ function\n8. Effective methods of contraception during the study\n\nExclusion Criteria:\n\n1. Progression or other malignancy requiring treatment within 5 years prior to enrollment\n2. Prior targeted therapy for KRAS G12D\n3. With central nervous system metastasis\n4. Uncontrolled fluid accumulation\n5. Other anticancer therapy within 4 or 5 half-lives (whichever is shorter) before treatment\n6. Concomitant clinically significant cardiovascular disease\n7. Concurrent major acute or chronic infectious disease\n8. 4\\. Subjects who have undergone other major surgery other than diagnostic or biopsy, or are expected to undergo major surgery during the study;\n9. History of severe mental or psychological illness or drug abuse or a history of severe alcohol abuse\n10. Other situations not suitable for the study judged by the investigator","ALL","18 Years","75 Years",{"count":19,"type":20},465,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation.The study consists of two stages I, Stage I ：explores the combination dose and the second phase; Stage II ：patients were randomized 1:1 to receive either the experimental regimen DN022150 plus AG or the control regimen AG alone.",[27,28],"Pancreatic Cancer","Pancreatic Carcinoma","NOT_YET_RECRUITING","2026-06-15",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":20},"2027-06-06",{"date":37,"type":20},"2029-05-08",{"name":39,"class":40},"Jiangxi Kvvit Pharmaceutical Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":15,"minAge":16,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100640716","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-kr25102-in-healthy-volunteers-100640716","NCT07618156","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Adult Chinese Participants","Inclusion Criteria:\n\n1. Male and female participants aged between 18 and 55 years inclusive (as of the time of signing the informed consent form);\n2. Male participants with body weight ≥ 50 kg and female participants with body weight ≥ 45 kg, with a body mass index (BMI) ranging from 19 to 26 kg\u002Fm² (inclusive of boundary values);\n3. Participants and their partners have no plans for conception, sperm donation or oocyte donation from signing the informed consent form until 2 months after the last dose of study drug, and are willing to adopt highly effective contraceptive measures;\n4. Female participants: not pregnant or breastfeeding; female participants of child-bearing potential must have negative serum pregnancy test results at screening and baseline visits;\n5. For groups requiring pain testing: willing to undergo pain tests and pass training; with no wounds or skin diseases on the skin at the pain-stimulated site;\n6. Participants fully understand the purpose, requirements and potential risks of this trial, are willing to strictly comply with all trial requirements, voluntarily participate in the clinical trial and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with previous or current clinical acute or chronic diseases including but not limited to cardiovascular, endocrine-metabolic, neuropsychiatric, digestive, respiratory, hematopoietic-lymphoid, immune, urinary, musculoskeletal diseases and malignant tumors, who are judged unsuitable for enrollment by the investigator;\n2. Subjects with personal or family history of hereditary angioedema;\n3. Subjects who have undergone major surgery within 6 months prior to screening, or plan to receive surgical operations during the trial;\n4. Subjects who have taken any medicines or health supplements (including Chinese herbal medicines) within 14 days before dosing; or those who are known to require other drug treatments during the trial at screening.\n5. Subjects who have used any hepatic enzyme inhibitors\u002Finducers within 1 month before dosing (inhibitors such as itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin or nefazodone; inducers such as carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.).\n6. Subjects who have participated in any clinical trials with investigational drugs\u002Fdevices within 3 months prior to screening, or plan to participate in other clinical trials during the study.\n7. Subjects with a history of drug abuse or positive results in drug abuse screening;\n8. Subjects with clinically significant abnormal physical examination results at screening or baseline as judged by the investigator;\n9. Subjects with positive screening results for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody;\n10. Subjects with cardiac diseases including but not limited to congenital long QT syndrome, torsades de pointes or risk factors for torsades de pointes (e.g., cardiac insufficiency, family history of long QT syndrome), those currently receiving Class IA anti-arrhythmic drugs (e.g., quinidine or procainamide), Class III anti-arrhythmic drugs (e.g., amiodarone or sotalol) or other drugs known to affect QT interval, or those with Fridericia-corrected QT interval (QTcF) ≥ 450 ms (male), QTcF ≥ 460 ms (female), PR interval \\> 200 ms or QRS interval ≥ 120 ms at screening;\n11. Subjects who fail pain test training as judged by the investigator (only applicable to groups requiring pain testing).",true,"55 Years",{"count":51,"type":20},83,[53],"PHASE1","Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.\n\nPhase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic\u002FPharmacodynamic characteristics of multiple administrations were evaluated.",[56],"Healthy Volunteers (HV)",[58],"KR25102, Pharmacokinetics, Safety","2026-05-25",{"date":61,"type":33},"2026-06-01",{"date":63,"type":20},"2026-06",{"date":65,"type":20},"2027-03",{"name":39,"class":40},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":48,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100640293","phase-1-a-phase-i-clinical-trial-to-evaluate-the-safety-tolerability-and-pharmacokinetic-characteristics-of-kr23248-capsules-in-healthy-adult-subjects-100640293","NCT07585383","A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects","A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single and Multiple Doses of KR23248 Capsules in Healthy Adult Subjects","Inclusion Criteria:\n\n1. Healthy male\u002Ffemale subjects aged ≥ 18 years and ≤ 45 years (inclusive) at the time of signing the informed consent form.\n2. Body Mass Index (BMI) ranging from 18.5 to 28.0 kg\u002Fm² (inclusive) at screening; male subjects with body weight ≥50 kg and female subjects with body weight ≥45 kg.\n3. Subjects who voluntarily participate in the trial and sign the informed consent form after understanding the purpose, content, procedures, and potential risks of the trial.\n4. Subjects who can communicate well with the investigators, are willing and able to comply with lifestyle restrictions specified in the protocol, and cooperate with study procedures.\n\nExclusion Criteria:\n\n1. Subjects with any diseases or dysfunctions in present illness and medical history that may interfere with the clinical trial, including but not limited to neurological and psychiatric diseases, cardiovascular diseases (e.g., congenital long QT syndrome), urinary system disorders, digestive system disorders, respiratory system disorders, musculoskeletal system disorders, metabolic and endocrine system disorders, skin diseases, hematological diseases, immune system diseases, and tumors.\n2. Subjects with any surgical condition or medical history that may significantly affect drug absorption, distribution, metabolism and excretion, or may pose a risk to the subject participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, and history of gastrointestinal bleeding.\n3. Subjects with a history of severe allergic reactions or known hypersensitivity to any ingredients of the investigational product.\n4. Subjects with current or previous psychiatric disorders or cerebral dysfunction; those assessed to be at suicide risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS), or by the investigator's clinical assessment, or those with a history of self-harm behavior.\n5. Subjects with a history of substance abuse within 1 year prior to administration or with a positive urine drug screening result.\n6. Subjects with a history of alcohol abuse within 6 months prior to screening (i.e., more than 14 standard units per week; 1 standard unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); or with a positive breath alcohol test; or unwilling to abstain from alcohol and any alcohol-containing products from screening until the last PK blood collection.\n7. Subjects with a history of surgery within 3 months prior to screening, or who have not recovered from surgery, or have a planned surgery scheduled during the trial.\n8. Subjects who have donated blood or experienced blood loss ≥ 400 mL within 3 months prior to screening, or ≥ 200 mL within one month, or have a history of blood product transfusion.\n9. Subjects who have participated in any clinical trial and received investigational drugs or medical devices within 3 months prior to screening.\n10. Subjects who have received vaccination within 30 days prior to screening, or have a vaccination plan during the entire study period.\n11. Subjects who have taken any medications within 28 days or 5 half-lives (whichever is longer) prior to screening and during the entire study period, including prescription drugs, over-the-counter drugs, herbal medicines, and any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inducers and\u002For inhibitors of CYP3A4, CYP2D6, and CYP3A5).\n12. Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test; or those who refuse to adopt effective non-pharmacological contraceptive measures (e.g., abstinence, intrauterine device, condoms with vaginal spermicide) throughout the study period and within 28 days after the end of administration; or those with a plan to donate sperm or ova.\n13. Subjects with clinically significant abnormal findings judged by the investigator in comprehensive physical examination, vital signs, laboratory tests and 12-lead electrocardiogram; including but not limited to: QTc \\> 450 ms in males and \\> 470 ms in females (Fridericia correction); resting pulse rate \\\u003C 55 beats\u002Fmin or \\> 100 beats\u002Fmin; systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg; diastolic blood pressure \\\u003C 60 mmHg or ≥ 90 mmHg.\n14. Subjects with non-negative results for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Human Immunodeficiency Virus antibody (HIV-Ab), and Toluidine Red Untreated Serum Test (TRUST).\n15. Subjects with alanine transaminase (ALT), creatinine (Cr) or serum prolactin level exceeding 2 times the upper limit of normal during the screening period.\n16. Subjects who smoke an average of ≥ 5 cigarettes per day within 3 months prior to screening, or are unable to abstain from any tobacco products during the trial.\n17. Subjects with an average daily intake of ≥ 5 cups of coffee or tea (200 mL per cup) within 3 months prior to screening, or are unable to discontinue intake during the trial.\n18. Subjects with special dietary requirements who cannot follow a unified study diet, or have difficulty in swallowing.\n19. Subjects who have consumed food or beverages containing grapefruit and\u002For pomelo within 7 days prior to administration.\n20. Subjects who have consumed xanthine-rich food or beverages (e.g., tea, coffee, cola, chocolate) within 3 days prior to administration.\n21. Subjects with poor compliance or other conditions deemed unsuitable for participation in the trial by the investigator.","45 Years",{"count":77,"type":20},66,[53],"This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China. It will enroll male and female participants aged 18 years to 45 years.",[81],"Schizophrenia","2026-05-12",{"date":84,"type":33},"2026-05-15",{"date":86,"type":20},"2026-05-19",{"date":88,"type":20},"2026-11",{"name":39,"class":40},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":48,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100624460","phase-1-study-of-single-and-multiple-ascending-doses-of-kr23343-in-healthy-adult-participants-100624460","NCT07409922","Study of Single and Multiple Ascending Doses of KR23343 in Healthy Adult Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KR23343, and an Open-Label Assessment of Food's Effect on Its Pharmacokinetics in Healthy Adults","Inclusion Criteria:\n\n1. Healthy male or female participants aged 18 to 45 years, inclusive.\n2. Body mass index (BMI) between 19 and 28 kg\u002Fm² (inclusive) and body weight ≥ 50 kg for males or ≥45 kg for females.\n3. All screening assessments (vital signs, physical examination, laboratory tests, ECG) must be within normal limits or deemed not clinically significant by the investigator. One repeat assessment is permitted during the screening period to confirm eligibility.\n4. Participants must agree not to donate gametes (sperm or ova), must not be planning pregnancy, and must use a reliable contraceptive method from the time of informed consent signing through 3 months following the last dose.\n5. Able to understand study requirements, provide written informed consent, and comply with all trial procedures per protocol.\n\nExclusion Criteria:\n\n1. Hypersensitivity or allergic to KR23343.\n2. History of severe hypersensitivity reactions or multiple drug\u002Ffood allergies\n3. Significant disease affecting the central nervous, cardiovascular, gastrointestinal, respiratory, renal, hematologic, metabolic, or musculoskeletal systems, or any condition considered by the Investigator to make the participant unsuitable for the trial.\n4. Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, or excretion, or compromise participant safety, including but not limited to urinary tract obstruction, dysuria, gastroenteritis, peptic ulcer disease, or history of gastrointestinal bleeding.\n5. History of psychiatric disorders or cerebral dysfunction; suicidal ideation identified by the Columbia-Suicide Severity Rating Scale (C-SSRS) or investigator judgment; or history of self-harm behavior.\n6. Abnormal screening investigations meeting any of the following criteria: a) Hepatic dysfunction: ALT or AST\\>1.5x upper limit of normal (ULN), or total bilirubin \\>1.3x ULN; b) Creatinine clearance \\\u003C80 mL\u002Fmin (calculated by Cockcroft-Gault formula: CrCl = \\[(140 - age) × weight (kg)\\] \u002F \\[0.814 × Scr (μmol\u002FL)\\], multiplied by 0.85 for females); c) Vital signs outside specified ranges (heart rate \\\u003C50 or \\>100 bpm, systolic blood pressure \\\u003C90 or ≥140 mmHg, diastolic blood pressure \\\u003C60 or ≥90 mmHg, tympanic temperature \\\u003C35.7 or \\>38.0°C); d) QTc-F interval ≥450 ms (males) or ≥470 ms (females), or other clinically significant ECG abnormalities; e) Any other screening abnormality deemed clinically significant by the investigator.\n7. Blood loss or donation ≥400 mL within 3 months prior to screening, or planned donation during the study.\n8. Use of any medication within 2 weeks (or 5 half-lives, whichever is longer) prior to screening or during the study, including prescription drugs, over-the-counter medications, Chinese herbal products, dietary supplements, vaccines, or any drug known to induce or inhibit hepatic metabolizing enzymes (e.g., CYP3A4, CYP3A5).\n9. Participation in a clinical trial involving investigational products, vaccines, or devices within 3 months prior to screening, or within 5 half-lives of the last dose, whichever is longer.\n10. History of drug abuse or illicit drug use within 6 months prior to screening, or positive urine drug screen.\n11. Hazardous alcohol consumption ( \\>14 units\u002Fweek; 1 unit = 360 mL beer, 25 mL 40% spirits, or 100 mL wine) within 6 months prior to screening, inability to abstain from screening through end-of-study, or positive alcohol breath test.\n12. Smoking \\>10 cigarettes per day within the 3 months prior to screening, or inability to abstain from smoking and nicotine products during the trial.\n13. Regular consumption of \\>8 cups\u002Fday (1 cup = 250 mL) of grapefruit juice, tea, coffee, or caffeinated beverages within the 3 months prior to screening, or inability to abstain during the trial.\n14. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.\n15. Pregnancy, lactation, or clinically significant abnormal pregnancy test as judged by the investigator.\n16. Specific dietary restrictions or inability to adhere to the standardized diet during their CPU stay.\n17. Difficult venous access, history of vasovagal syncope (needle or blood phobia), or inability to tolerate venipuncture.\n18. Any condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study.",{"count":98,"type":20},92,[53],"This is a Phase I, single-center trial to assess the safety, tolerability, PK and food effect of KR23343 in healthy volunteers. The study will be conducted in 3 sequential stages:\n\nStage 1: Single-Ascending-Dose (SAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability, and PK of single ascending doses of KR23343.\n\nStage 2: Food-Effect (FE) study An open-label, randomized, two-period, two-sequence crossover study to evaluate the effect of food on the PK of a single dose of KR23343.\n\nStage 3: Multiple-Ascending-Dose (MAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, and PK of repeated once-daily administration of KR23343 for 10 days.",[102],"Healthy","2026-02-08",{"date":105,"type":33},"2026-02-13",{"date":107,"type":20},"2026-02-03",{"date":109,"type":20},"2026-11-20",{"name":39,"class":40},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":48,"sex":15,"minAge":16,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100619497","phase-2-safety-efficacy-and-pharmacokinetic-characteristics-of-kr230109-cream-in-facial-acne-vulgaris-100619497","NCT07345390","Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 Cream in Facial Acne Vulgaris","A Multicenter, Double-blind, Placebo-parallel-controlled Phase Ⅱ Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 in Patients With Acne Vulgaris","Inclusion Criteria:\n\n1. Age between 18 and 40 years old (as of the time of signing the informed consent form), regardless of gender;\n2. Patients clinically diagnosed with mild to moderate facial acne vulgaris (refer to the \"Chinese Acne Treatment Guidelines\" 2019 revised edition), and with an overall facial IGA (Investigator Global Assessment) score of 2 to 3 by the study doctor;\n3. Baseline requirements: For patients with mild to moderate acne, the count of facial inflammatory lesions (papules and\u002For pustules) should be \\>=10 and \\\u003C=40; the count of non-inflammatory lesions (open and\u002For closed comedones) should be \\>=20 and \\\u003C=60; no facial nodules should exist;\n4. Participants must be willing to use only non-acne-treating skin care products during the trial and comply with the precautions required by the protocol;\n5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form, and be able to complete the entire trial process as required;\n6. From the time of signing the informed consent form to 3 months after the last administration, female participants of childbearing age or male participants whose partners are of childbearing age must agree and be able to take effective contraceptive measures, such as avoiding sexual activity or using reliable contraceptive methods like condoms or intrauterine devices.\n\nExclusion Criteria:\n\n1. Those known to be allergic to KR230109 or drugs with the same mechanism of action such as tazarotene, adapalene, or any of their components;\n2. Those with a history of any serious clinical systemic diseases or surgeries, such as diseases of the circulatory system, nervous system, hematological system, immune system, or mental system;\n3. Those with concurrent other obvious skin diseases at the affected area that may affect the clinical evaluation of the researchers or require concurrent treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, eczema, severe acne, and extremely severe acne (such as conglobate acne, fulminant acne, etc.);\n4. Those with secondary acne, such as occupational acne and acne caused by corticosteroids;\n5. Those with facial skin or hair conditions that may interfere with clinical assessment (such as significant beards, sideburns, or mustaches);\n6. Those who plan to use any adjunctive therapies or concomitant treatments for acne during the trial;\n7. Those who have used acne-specific functional skin care products within one week before the start of treatment;\n8. Those who have used topical retinoids, antibiotics, corticosteroids, or other topical acne treatments on the face within two weeks before the trial;\n9. Those who have taken oral retinoids, antibiotics, corticosteroids (including intramuscular or intralesional injections, except for stable use of inhaled, intranasal, or intraocular corticosteroids for the treatment of underlying diseases and without impact on acne treatment), spironolactone, or other acne medications within four weeks before the trial;\n10. Those who have undergone physical or chemical acne treatments within four weeks before the trial;\n11. Those who have participated in other clinical trials and used trial drugs or medical devices within 90 days before screening or plan to participate in other clinical trials during the trial;\n12. Those whose vital signs, physical examinations, laboratory tests (blood routine, urine routine, blood biochemistry), electrocardiograms, etc., are abnormal and have clinical significance as assessed by the researchers and may affect the evaluation of this trial;\n13. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis-specific antibody, or human immunodeficiency virus antibody;\n14. Pregnant or lactating women or those with positive blood or urine pregnancy tests;\n15. Those who need prolonged or excessive exposure to sunlight, such as sunbathing;\n16. Those with a history of alcohol abuse or drug abuse;\n17. Those who, in the opinion of the researchers, have poor compliance, or have conditions that may interfere with the study outcome, or those who, in the opinion of the researchers, have any other conditions that make them unsuitable for participation in this clinical trial.","40 Years",{"count":120,"type":20},180,[23],"This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris",[124],"Acne Vulgaris","2026-01-08",{"date":127,"type":33},"2026-01-15",{"date":129,"type":20},"2026-01-10",{"date":131,"type":20},"2026-11-30",{"name":39,"class":40},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100601661","phase-3-a-study-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-suraxavir-marboxil-for-suspension-100601661","NCT07113392","A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension","A Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Suraxavir Marboxil for Suspension in Pediatric Patients (2 to \u003C12 Years) With Uncomplicated Influenza","Inclusion Criteria:\n\n1. Male or female participants aged 2 to 12 years (≥2 years and \\\u003C12 years).\n2. body weight≥10 kg at screening.\n3. Diagnosed with influenza virus infection based on the following criteria:\n\n   * Positive rapid antigen test (RAT) result from a throat or nasal swab for influenza virus (rapid nucleic acid tests or other rapid molecular diagnostic tests are also acceptable); and\n   * Fever at screening (tympanic temperature ≥38.0°C or axillary temperature ≥37.5°C). If antipyretics were taken, fever must be present \\>1 hour after administration, or If fever subsided (tympanic \\\u003C38.0°C or axillary \\\u003C37.5°C) after antipyretic use, fever must have recurred \\>4 hours after administration; and\n   * Presence of at least one moderate or more severe respiratory symptom at screening (including cough, and\u002For nasal congestion or rhinorrhea).\n4. Time interval between the onset of illness symptoms and enrollment is ≤48 hours.\n\n   Onset of illness: defined as the time of the first temperature increase (tympanic temperature ≥38.0°C or axillary temperature ≥37.5°C) or time of first appearance (or caregiver observation) of at least one respiratory symptom associated with influenza virus infection.\n5. The participant's legal guardian agrees to the child's participation in the clinical study and signs the informed consent form (ICF). Participants aged ≥8 years must also voluntarily sign the ICF.\n6. The investigator assesses that the participant and\u002For the caregiver can comply with the protocol requirements, follow-up visits, and complete all study procedures and evaluations (e.g., completing the diary card).\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the active ingredient or excipients of the investigational product.\n2. Patients diagnosed with severe or critical influenza at screening: (1) Severe influenza cases were defined by the presence of one or more of the following conditions: a. Dyspnea and\u002For tachypnea without fever: \\>30 breaths\u002Fmin (age \\>5 years), \\>40 breaths\u002Fmin (age 2-5 years).b. Altered mental status (e.g., lethargy, agitation, seizures).c. Severe vomiting\u002Fdiarrhea with moderate-to-severe dehydration.d. Concurrent pneumonia.e. Significant exacerbation of pre-existing comorbidities.(2) Critical influenza cases were defined by the presence of one or more of the following conditions: a. Respiratory failure.b. Acute necrotizing encephalopathy.c. Septic shock.d. Multiorgan dysfunction.e. Other life-threatening conditions requiring intensive care.\n\n   Note: Based on \"Expert Consensus on Diagnosis and Treatment of Influenza in Children (2020 Edition)\".\n3. History of gastrointestinal diseases affecting drug absorption (e.g., reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, post-gastrectomy).\n4. Bronchitis, pleural effusion, or interstitial pneumonia suspected by investigator or confirmed by chest imaging.\n5. Use of anti-influenza antiviral drugs within two weeks before screening (e.g., neuraminidase inhibitors \\[oseltamivir, zanamivir, peramivir\\], cap-dependent endonuclease inhibitors \\[baloxavir marboxil\\], hemagglutinin inhibitors \\[arbidol\\], M2 inhibitors \\[amantadine, rimantadine\\], or other NMPA-approved anti-influenza agents).\n6. Clinically relevant abnormal results in physical examination, 12-lead ECG, vital signs, hematology, clinical biochemistry, or urinalysis at screening, which in the investigator's judgment may pose a risk to the participant's safety, affect the study results, or impact the participant's ability to complete the study.\n7. Acute respiratory infection (excluding current influenza), otitis media, or sinusitis within 2 weeks pre-screening.\n8. Co-infection requiring systemic antibiotics or other systemic therapy at screening.\n9. Known\u002Fsuspected active primary\u002Fsecondary immunodeficiency (including HIV infection, hematologic malignancies causing severe immunodeficiency).\n10. Known or suspected congenital abnormalities of the heart or lungs, or severe primary diseases affecting the cardiovascular, hepatic, renal, or hematopoietic systems, or evidence of active liver disease, including but not limited to jaundice or AST\u002FALT levels exceeding two times the upper limit of normal (ULN) at screening.\n11. Positive serology for hepatitis B surface antigen or a history of hepatitis B infection at screening.\n\n    (Note: participants with HBV vaccination history and no prior HBV infection are exempt from this exclusion after medical history review).\n12. History of mental illness, intellectual disability, substance abuse, or other adverse conditions (e.g., inability to read, understand, or write) that, in the investigator's judgment, may limit participation in the study.\n13. Influenza vaccination within 6 months pre-screening or planned during the study. (Note: Vaccination history must be verified by medical history review).\n14. Participation in any interventional clinical trial (drug\u002Fdevice) within 30 days pre-screening.\n15. Intolerance to skin puncture, fainting at the sight of blood or needles, or poor venous access for blood collection at screening.\n16. Any other condition deemed unsuitable by the investigator.","2 Years","12 Years",{"count":143,"type":20},144,[24],"This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to \\\u003C12 Years) with Uncomplicated Influenza.",[147],"Influenza","2025-08-04",{"date":150,"type":33},"2025-08-08",{"date":152,"type":20},"2025-08-01",{"date":154,"type":20},"2026-08-01",{"name":39,"class":40},""]