[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhuhai United Laboratories Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":41},"100651497","phase-1-to-evaluate-safety-tolerability-pkpd--food-effect-of-singlemultiple-oral-tul321-capsules-in-healthy-participants-100651497",false,"NCT07760467","To Evaluate Safety, Tolerability, PK\u002FPD & Food Effect of Single\u002FMultiple Oral TUL321 Capsules in Healthy Participants.","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single and Multiple Doses of TUL321 Capsule in Healthy Participants, and the Effect of Food on Pharmacokinetics","Inclusion Criteria:\n\n1. Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.\n2. Age 18-45 years (inclusive) at informed consent, male or female.\n3. Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg\u002Fm² (inclusive).\n4. Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.\n5. For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.\n\nExclusion Criteria:\n\n1. Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug\u002Ffood allergies.\n2. Past history of tuberculosis infection or active tuberculosis at screening.\n3. Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.\n4. Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.\n5. History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.\n6. Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.\n7. QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.\n8. eGFR \\\u003C90 mL\u002Fmin\u002F1.73 m² (calculated by CKD-EPI formula) at screening.\n9. Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.\n10. Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.\n11. Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).\n12. Average daily cigarette consumption \\>5 cigarettes within 3 months before screening.\n13. History of drug\u002Fsubstance abuse within 6 months before screening, or positive drug abuse screening test.\n14. Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.\n15. Required or plan to perform heavy physical labor or strenuous exercise during study participation.\n16. Pregnant or lactating women, or women of child-bearing potential with positive pregnancy test at screening.\n17. Acute illness or concomitant medication occurs from screening to pre-first-dose.\n18. Cannot tolerate high-fat meal (applies only to subjects in the food-effect sub-study).\n19. Difficulty swallowing, intolerance to venipuncture, or history of needle-syncope or blood-syncope.\n20. Investigator judges that the subject is unsuitable for this study for any other reason.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},94,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK",[28],"Paroxysmal Nocturnal Hemoglobinuria, PNH","NOT_YET_RECRUITING","2026-08-09",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":22},"2026-08-26",{"date":37,"type":22},"2027-05-08",{"name":39,"class":40},"Zhuhai United Laboratories Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100648192","phase-1-evaluation-of-the-safety-tolerability-and-pharmacokinetics-of-tul108-for-injection-in-healthy-participants-sad-mad-100648192","NCT07719257","Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD\u002F MAD)","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of TUL108 for Injection After Single and Multiple Intravenous Infusions in Healthy Participants.","Inclusion Criteria:\n\n1. Participants must sign the informed consent form prior to the study, fully understand the study, procedures, and potential adverse reactions, and be voluntary participate in and able to complete the study as required by the protocol.\n2. Male or female participants aged 18-45 years (inclusive).\n3. Body weight of not less than 50.00 kg for male participants and 45.00 kg for female participants with body mass index (BMI) within the range of 19.0-27.0 kg\u002Fm2 (inclusive).\n4. Female participants of childbearing potential, or male participants whose partners are of childbearing potential, must have no plans for pregnancy, sperm\u002Fegg donation from signing the informed consent until 3 months after the last dose, and must be voluntary to use highly effective contraception (including their partners) (non-pharmacological contraception is required during the study).\n\nExclusion Criteria:\n\n1. Having a clinically significant severe disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, pulmonary, immunological, psychiatric, or cardiovascular and cerebrovascular diseases) within 12 months prior to screening.\n2. Participants with clinically significant abnormalities in laboratory tests, physical examination, vital signs, electrocardiogram (ECG), posteroanterior chest X-ray, or abdominal ultrasound.\n3. Female participants who are pregnant or lactating.\n4. Participants with acute illness or requiring concomitant medication from screening to the first dose.\n5. Participants who are unable to tolerate venipuncture or have a history of needle phobia or hemophobia.\n6. Participants who are unsuitable for the study as assessed by the investigator due to any other factors.",{"count":50,"type":22},72,[25],"To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.",[54],"Complicated Urinary Tract Infections(cUTI)","2026-07-17",{"date":57,"type":33},"2026-07-22",{"date":59,"type":22},"2026-07-30",{"date":61,"type":22},"2026-12-30",{"name":39,"class":40},""]