[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Consun Pharmaceutical Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100613471","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pk-of-sk-09-100613471",false,"NCT07267026","A Study to Evaluate the Safety, Tolerability and PK of SK-09","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of SK-09 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.\n2. Weight and BMI for female and male participants:\n\n   Body weight ≥ 50 kg; Body mass index (BMI) between 18.5 and 29.9 kg\u002Fm2 (inclusive)\n3. Participants must be in good general health.\n4. Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.\n5. Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .\n\nExclusion Criteria:\n\n1. History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic\u002Fimmunologic disorders.\n2. Chronic GI conditions requiring daily medication; or history of bariatric surgery.\n3. Live\u002Fattenuated vaccines within 4 weeks prior to dosing or planned during study.\n4. Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.\n5. History of myocardial infarction, angina, coronary artery bypass grafting, angioplasty, stenting, congestive heart failure, uncontrolled hypotension, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms\u002Ffamily history of QT prolongation syndrome, as assessed by the investigator to be unsuitable for participation.\n6. Positive results for hepatitis B surface antigen, syphilis-specific antibodies, hepatitis C antibodies, or HIV antibodies.\n7. Major surgery or trauma requiring hospitalization within 6 months.\n8. Hypersensitivity to any component of SK-09 or its excipients.\n9. Poor venous access or needle phobia impacting study procedures.\n10. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months.\n11. Current smokers unwilling to abstain during study.\n12. Participants with ANY of the following abnormalities in clinical laboratory tests at screening and confirmed by a single repeat test, if deemed necessary:\n\n    * AST or ALT level ≥ 1.5×ULN;\n    * Total bilirubin level ≥ 1.5×ULN (except Gilbert's with direct bilirubin ≤ ULN)\n13. Blood loss or donation exceeding 400 mL within 3 months of dosing.\n14. Other investigational product within 30 days of dosing or 5 half-lives (whichever longer).\n15. Use of any medications, including over-the-counter drugs, herbal medicine, vitamins, and health supplements, within 2 weeks prior to the first dose or 5 half-lives (whichever longer).\n16. Positive pregnancy test or breastfeeding.\n17. Unprotected sexual activity within 2 weeks prior to the first dose.\n18. Any condition that, in the investigator's opinion, may pose a safety risk to the participant, interfere with the study, or prevent the participant from completing the study or complying with its requirements (due to administrative or other reasons).\n19. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This Phase 1 trial consists of two parts: Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design.",[28,29],"FSGS","MCD","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-05","ACTUAL",{"date":36,"type":34},"2025-12-08",{"date":38,"type":22},"2026-10-04",{"name":40,"class":41},"Consun Pharmaceutical Group","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100594569","phase-1-a-study-to-evaluate-the-safety-tolerability-and-pk-of-sk-08-100594569","NCT07021157","A Study to Evaluate the Safety, Tolerability and PK of SK-08","A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants","SK-08","Inclusion Criteria:\n\n1. Healthy male and female participants aged 18 to 45 years (inclusive).\n2. Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg\u002Fm².\n3. Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .\n4. Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Have a specific history of allergies or have an allergic constitution；\n2. Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.\n3. Developed acute diseases from 2 weeks before screening to before randomization ;\n4. Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;\n5. Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;\n6. Those who have used any drugs or health supplements from 2 weeks before screening to randomization ;\n7. Any drugs that may interact with this product have been used from 30 days before screening to randomization, such as CYP450 inhibitors or inducers ;\n8. Those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion;\n9. Those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial;\n10. Those who had a history of alcohol abuse within one year before screening；\n11. Those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period;\n12. Those who cannot tolerate venipuncture\u002Findwelling needles or have a history of fainting from needles or blood ;\n13. Other researchers determined that the subjects were not suitable to participate.","45 Years",{"count":53,"type":22},48,[25],"The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.",[57],"Chronic Kidney Disease(CKD)",[57],"2025-06-18",{"date":61,"type":34},"2025-06-24",{"date":63,"type":34},"2025-03-09",{"date":65,"type":22},"2025-08-07",{"name":40,"class":41},""]