[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Qilu Pharmaceutical Research and Development Center LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,62],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651315","phase-1-phase-i-study-of-qls1510-tablets-in-healthy-participants-100651315",false,"NCT07760077","Phase I Study of QLS1510 Tablets in Healthy Participants","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of QLS1510 Tablets in Healthy Adult Participants","Key Inclusion Criteria:\n\n1. Male and female adults aged between 18 and 45 years, inclusive, at the time of informed consent,\n2. Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations as assessed by the Investigator,\n3. Body weight ≥50 kg for males and ≥45 kg for females with a body mass index (BMI) between 18.0 and 26.0 kg\u002Fm2,\n4. Participants (including their partners) confirm they have no plans to donate sperm or egg, undergo in vitro fertilization (IVF), or become pregnant, and they agree to use highly effective contraceptive methods.\n5. Understand and comply with the study procedures and methods, voluntarily participate in the trial, and provide written informed consent.\n\nKey Exclusion Criteria:\n\n1. Participants with any disease identified at screening that warrants exclusion in the Investigator's judgment,\n2. Participants with a history of severe allergic reactions (e.g., angioedema or anaphylactic shock), atopic diathesis (e.g., pollen allergy, allergy to two or more drugs or foods), and\u002For known hypersensitivity to the IP or any of its components,\n3. Participants with functional asplenia, history of splenectomy, or prior exposure to immunosuppressive therapies or agents, or any other condition that, in the investigator's judgment, compromises immune function,\n4. Participants with positive test results for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), or positive hepatitis C virus antibody (HCVAb), Treponema pallidum-specific antibody, or human immunodeficiency virus (HIV) antibody during the screening period,\n5. Participants with a 12-lead ECG at screening\u002Fbaseline showing QTcF (QT corrected per Fridericia's formula) \\> 450 msec for males and \\> 470 msec for females,\n6. Participants with supine systolic blood pressure ≥140 mmHg or \\\u003C90 mmHg or diastolic blood pressure ≥90 mmHg or \\\u003C60 mmHg after resting in the supine position for at least 5 minutes at screening\u002Fbaseline,\n7. Participants with pulse or heart rate (HR) \\> 100 or \\\u003C 50 bpm after at least 5 minutes of rest at screening\u002Fbaseline,\n8. Participants with any of the following laboratory abnormalities at screening\u002Fbaseline:\n\n   1. ALT or AST \\> upper limit of normal (ULN);\n   2. Total bilirubin \\> 1.5 ULN (direct bilirubin can be measured in participants with a history of Gilbert's syndrome, and participants can be enrolled into this study if direct bilirubin ≤ ULN),\n9. Participants with an estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m² at screening\u002Fbaseline, calculated using the Modification of Diet in Renal Disease (MDRD) formula,\n10. Participants with a serious infection (e.g., requiring hospitalization, systemic antibacterial therapy, or opportunistic infections) within 6 months prior to screening, or with a history of chronic or recurrent infectious disease that, in the opinion of the investigator, may preclude safe study participation,\n11. Participants who have received a live (attenuated) vaccine within 6 weeks prior to the first dose of IP, or who plan to receive a live (attenuated) vaccine during the study period or within 8 weeks after the last dose of IP,\n12. Participants who have participated in clinical trials of another investigational product,\n13. Participants who have experienced major trauma,\n14. Participants with an acute illness (e.g., nausea, vomiting, fever, or diarrhea) within 1 week prior to the first dose of IP,\n15. Pregnant or breastfeeding women or participants with a positive pregnancy test result,\n16. Participants who, in the investigator's judgment, may be at increased risk of study-related complications, may interfere with the interpretation of study results, or are otherwise unsuitable for study participation.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants",[28],"Inflammatory Bowel Disease (IBD)","NOT_YET_RECRUITING","2026-08-09",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":22},"2026-08-30",{"date":37,"type":22},"2027-04-30",{"name":39,"class":40},"Shanghai Qilu Pharmaceutical Research and Development Center LTD","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100635414","phase-1-this-study-aims-to-evaluate-the-efficacy-and-safety-of-qls1317-in-patients-with-msi-hdmmr-advanced-solid-tumors-100635414","NCT07552376","This Study Aims to Evaluate the Efficacy and Safety of QLS1317 in Patients With MSI-H\u002FdMMR Advanced Solid Tumors.","A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS1317 in Participants With Advanced Solid Tumors Characterized by Microsatellite Instability-High (MSI-H)\u002FDeficient DNA Mismatch Repair (dMMR) Advanced Solid Tumors","Inclusion Criteria:\n\n-1. Males or females aged ≥ 18 at the time of signing the informed consent form (ICF).\n\n2\\. Expected survival duration ≥ 3 months. 3. Participants with advanced solid tumors of MSI-H\u002FdMMR who have failed standard treatment.\n\n4\\. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) physical performance status score of 0-1.\n\n6\\. Patients with sufficient organ function.\n\nExclusion Criteria:\n\n* 1\\. Have a history of allergy to any component of the study drug. 2. Oral medication is not allowed. 3. The residual toxic reactions caused by previous anti-tumor treatment are higher than Grade 1 according to CTCAE v6.0.\n\n  4\\. Known or discovered during screening period to have active central nervous system metastasis.\n\n  5\\. Having suffered from other malignant tumors within 5 years prior to the first dose.\n\n  6\\. The presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require drainage or treatment.\n\n  7\\. Chronic active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.\n\n  8\\. Suffering from severe cardiovascular and cerebrovascular diseases. 9. Any severe or uncontrollable systemic disease. 10. Have received allogeneic tissue\u002Fsolid organ transplantation.",{"count":49,"type":22},120,[25],"The goal of this study aims to evaluate the efficacy and safety of QLS1317 in patients with MSI-H\u002FdMMR advanced solid tumors who failed standard treatment.",[53],"MSI-H or dMMR Advanced Solid Tumors","2026-04-20",{"date":56,"type":33},"2026-04-27",{"date":58,"type":22},"2026-05",{"date":60,"type":22},"2028-12",{"name":39,"class":40},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100588840","phase-1-a-phase-i-study-of-qls12010-capsules-safety-tolerability-pk-pd-and-food-effects-in-healthy-adults-and-moderate-to-severe-atopic-dermatitis-patients-100588840","NCT06946641","A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Ascending Doses of QLS12010 Capsules in Healthy Adult Participants and Participants With Atopic Dermatitis","Inclusion Criteria for Parts A-C:\n\n* Males and females aged 18-45 (inclusive),\n* Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg\u002Fm2 (inclusive),\n\nInclusion Criteria for Part D:\n\n* Female or male participants between the ages of 18 to 75 years of age.\n* Chronic AD diagnosed by the criteria of Hannifin and Rajka that has been present for at least 6 Months before the Screening Visit.\n* At screening and baseline: EASI score ≥ 16, vIGA-AD™ score ≥ 3, and BSA affected by AD ≥ 10%;\n* The weekly mean score of PP NRS ≥ 4 prior to the first administration (with assessment results for at least 4 days during the week before the first administration \\[D-7 to D-1\\]);\n* As judged by the investigator, within 6 months prior to screening, the patient had an inadequate response to topical medication therapy.\n\nGeneral Exclusion Criteria:\n\n* Participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervous system, psychiatric system, cardiovascular system, blood and lymphatic system, immune system, respiratory system, digestive system, urinary system, metabolic and skeletal system disorders,\n* The 12-lead ECG at screening shows QTcF (QT corrected using Fridericia's formula) \\> 450 ms. If QTcF is \\> 450 ms, the 12-lead ECG should be repeated 2 more times (at least 3 min apart), and the mean of the 3 measurements will be used to determine whether the participant meets the inclusion criteria,\n* Participants who smoke more than 5 cigarettes per day on average within 6 months before screening or are currently using e-cigarettes,\n* Participants who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening or have a positive breath alcohol test at screening,\n* Participants who have donated more than 400 mL of blood within 3 months or more than 200 mL of blood within 4 weeks before screening, or plan to donate blood during the study,\n* Participants who have received any strong inhibitor or inducer of CYP3A4 within 4 weeks before screening,\n* Participants who have received any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","75 Years",{"count":71,"type":22},102,[25],"The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. This study consists of four parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B, which consists of three multiple ascending doses (MAD) cohorts of QLS12010 Capsules. Part C is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions. Part D is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and preliminary efficacy of QLS12010 Capsules following multiple oral administrations in adult participants with atopic dermatitis (AD).",[75,76,77],"Atopic Dermatitis","Hidradenitis Suppurativa (HS)","Rheumatoid Arthritis (RA)","RECRUITING","2025-07-28",{"date":81,"type":33},"2025-07-31",{"date":83,"type":33},"2025-03-31",{"date":85,"type":22},"2026-04",{"name":39,"class":40},1,""]