[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657771":3},{"organization":4,"outcomesModule":7,"designInfo":204,"detailedDescription":213,"studyPopulation":203,"armGroups":214,"interventions":243,"overallOfficials":203,"centralContacts":253,"locations":203,"responsibleParty":259,"collaborators":263,"id":269,"slug":270,"hasResults":271,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":203,"eligibilityCriteria":275,"healthyVolunteers":276,"sex":277,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":203,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":290,"overallStatus":297,"whyStopped":203,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":203},{"fullName":5,"class":6},"The Third Xiangya Hospital of Central South University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":66,"otherOutcomes":203},[9,13,17,21,25,28,32,35,38,41,44,48,51,54,57,60,63],{"measure":10,"description":11,"timeFrame":12},"Adverse Events and Serious Adverse Events","Incidence, severity, seriousness, relationship, and outcome of adverse events and serious adverse events.","From informed consent through Day 2 discharge\u002Fearly termination; unresolved adverse events are followed as specified in the protocol.",{"measure":14,"description":15,"timeFrame":16},"Physical Examination Findings","Number of participants with clinically significant changes or abnormalities in physical examination findings.","Screening, Day -2 as applicable, Day -1, Day 2\u002Fend-of-study, and early termination.",{"measure":18,"description":19,"timeFrame":20},"Holter Monitoring Findings","Clinically significant abnormalities detected by protocol-specified Holter monitoring.","Time-matched baseline on Day -1; Day 1 from infusion start through 24 hours after infusion at protocol-specified time points (infusion start; 30 minutes, 1, 2, 3 hours after start; 2, 10, 30 minutes, 1, 4, 12, 24 hours after completion).",{"measure":22,"description":23,"timeFrame":24},"Plasma Cortisol Concentration","Plasma cortisol concentration (measured in nmol\u002FL) assessed by protocol-specified laboratory testing.","Screening (Day -14 to Day -2) at 07:00-08:00, 16:00 , and 00:00; time-matched baseline on Day -1; on Day 1, pre-dose, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 8 hours after infusion start, and at 16:00 and 00:00; and on Day 2 at 08:00.",{"measure":26,"description":27,"timeFrame":24},"Plasma Adrenocorticotropic Hormone Concentration","Plasma adrenocorticotropic hormone (ACTH) concentration (measured in pg\u002FmL) assessed by protocol-specified laboratory testing.",{"measure":29,"description":30,"timeFrame":31},"Blood Pressure","Change from baseline in blood pressure (systolic and diastolic, measured in mmHg) assessed by standard vital sign measurement.","Day 1: pre-dose; during infusion at 30 minutes, 1, 2, 3 hours; post-infusion at 30 minutes, 1, 2, 4, 8, 12, 24 hours; and at early termination.",{"measure":33,"description":34,"timeFrame":31},"Pulse Rate","Change from baseline in pulse rate (measured in beats per minute) assessed by standard vital sign measurement.",{"measure":36,"description":37,"timeFrame":31},"Respiratory Rate","Change from baseline in respiratory rate (measured in breaths per minute) assessed by standard vital sign measurement.",{"measure":39,"description":40,"timeFrame":31},"Body Temperature","Change from baseline in tympanic body temperature (measured in degrees Celsius) assessed by standard vital sign measurement.",{"measure":42,"description":43,"timeFrame":31},"Oxygen Saturation (SpO2)","Change from baseline in oxygen saturation (measured as percentage of oxygen saturation) assessed by pulse oximetry.",{"measure":45,"description":46,"timeFrame":47},"Heart Rate","Change from baseline in heart rate (measured in beats per minute) assessed by 12-lead electrocardiogram.","Pre-dose (within 1 hour before anesthesia induction); after completion of continuous infusion at 30 minutes (±5 minutes), 2 hours (±10 minutes), 4 hours (±10 minutes), 8 hours (±15 minutes), and 24 hours (±20 minutes); and at early termination.",{"measure":49,"description":50,"timeFrame":47},"PR Interval","Change from baseline in PR interval (measured in milliseconds) assessed by 12-lead electrocardiogram.",{"measure":52,"description":53,"timeFrame":24},"Change From Time-Matched Baseline in Plasma Cortisol Concentration","Change from time-matched baseline in plasma cortisol concentration (measured in nmol\u002FL) assessed by protocol-specified laboratory testing.",{"measure":55,"description":56,"timeFrame":47},"QRS Interval","Change from baseline in QRS interval (measured in milliseconds) assessed by 12-lead electrocardiogram.",{"measure":58,"description":59,"timeFrame":47},"QT Interval","Change from baseline in QT interval (measured in milliseconds) assessed by 12-lead electrocardiogram.",{"measure":61,"description":62,"timeFrame":47},"QTcF Interval","Change from baseline in QT interval corrected using Fridericia's formula (measured in milliseconds) assessed by 12-lead electrocardiogram.",{"measure":64,"description":65,"timeFrame":24},"Change From Time-Matched Baseline in Plasma Adrenocorticotropic Hormone Concentration","Change from time-matched baseline in plasma adrenocorticotropic hormone (ACTH) concentration (measured in pg\u002FmL) assessed by protocol-specified laboratory testing.",[67,71,75,78,81,83,86,89,92,95,98,101,103,105,107,109,111,113,115,117,119,121,123,125,127,129,131,133,135,137,139,141,143,145,149,153,156,160,164,168,172,176,180,184,188,192,195,199],{"measure":68,"description":69,"timeFrame":70},"Maximum Plasma Concentration (Cmax) of KL0011034","Maximum observed plasma concentration.","pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.",{"measure":72,"description":73,"timeFrame":74},"Time to Maximum Plasma Concentration (Tmax) of KL0011034","Time of the first occurrence of the maximum observed plasma concentration.","Pre-induction and pre-maintenance; during infusion at 5, 10, 20, 30, and 45 minutes and 1, 2, or 3 hours as applicable; after infusion at 2, 5, 10, 20, 30, and 40 minutes and 1, 2, 4, 8, 12, and 24 hours.",{"measure":76,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KL0011034","Calculated using the linear-up\u002Flog-down trapezoidal method.",{"measure":79,"description":80,"timeFrame":74},"Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034","Calculated as AUC0-t + Clast\u002Fλz.",{"measure":82,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034",{"measure":84,"description":85,"timeFrame":74},"Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of KL0011034","Calculated as \\[(AUC0-∞ - AUC0-t)\u002FAUC0-∞\\] × 100%.",{"measure":87,"description":88,"timeFrame":74},"Clearance (CL) of KL0011034","Calculated as Dose\u002FAUC0-∞, as applicable.",{"measure":90,"description":91,"timeFrame":74},"Volume of Distribution (Vd) of KL0011034","Calculated as Dose\u002F(AUC0-∞ × λz), as applicable.",{"measure":93,"description":94,"timeFrame":74},"Terminal Elimination Rate Constant (λz) of KL0011034","Estimated by log-linear regression of the terminal concentration-time phase using at least three points.",{"measure":96,"description":97,"timeFrame":74},"Terminal Elimination Half-Life (t1\u002F2) of KL0011034","Calculated as ln(2)\u002Fλz.",{"measure":99,"description":100,"timeFrame":74},"Mean Residence Time From Time Zero to Infinity (MRT0-∞) of KL0011034","Calculated as AUMC\u002FAUC0-∞.",{"measure":102,"description":69,"timeFrame":74},"Maximum Plasma Concentration (Cmax) of KL0011034 Metabolite A644S(A)-Z7",{"measure":104,"description":73,"timeFrame":74},"Time to Maximum Plasma Concentration (Tmax) of KL0011034 Metabolite A644S(A)-Z7",{"measure":106,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KL0011034 Metabolite A644S(A)-Z7",{"measure":108,"description":80,"timeFrame":74},"Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034 Metabolite A644S(A)-Z7",{"measure":110,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of KL0011034 Metabolite A644S(A)-Z7",{"measure":112,"description":85,"timeFrame":74},"Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of KL0011034 Metabolite A644S(A)-Z7",{"measure":114,"description":88,"timeFrame":74},"Clearance (CL) of KL0011034 Metabolite A644S(A)-Z7",{"measure":116,"description":91,"timeFrame":74},"Volume of Distribution (Vd) of KL0011034 Metabolite A644S(A)-Z7",{"measure":118,"description":94,"timeFrame":74},"Terminal Elimination Rate Constant (λz) of KL0011034 Metabolite A644S(A)-Z7",{"measure":120,"description":97,"timeFrame":74},"Terminal Elimination Half-Life (t1\u002F2) of KL0011034 Metabolite A644S(A)-Z7",{"measure":122,"description":100,"timeFrame":74},"Mean Residence Time From Time Zero to Infinity (MRT0-∞) of KL0011034 Metabolite A644S(A)-Z7",{"measure":124,"description":69,"timeFrame":74},"Maximum Plasma Concentration (Cmax) of Propofol",{"measure":126,"description":73,"timeFrame":74},"Time to Maximum Plasma Concentration (Tmax) of Propofol",{"measure":128,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Propofol",{"measure":130,"description":80,"timeFrame":74},"Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Propofol",{"measure":132,"description":77,"timeFrame":74},"Area Under the Curve From Time Zero to 24 Hours (AUC0-24h) of Propofol",{"measure":134,"description":85,"timeFrame":74},"Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Propofol",{"measure":136,"description":88,"timeFrame":74},"Clearance (CL) of Propofol",{"measure":138,"description":91,"timeFrame":74},"Volume of Distribution (Vd) of Propofol",{"measure":140,"description":94,"timeFrame":74},"Terminal Elimination Rate Constant (λz) of Propofol",{"measure":142,"description":97,"timeFrame":74},"Terminal Elimination Half-Life (t1\u002F2) of Propofol",{"measure":144,"description":100,"timeFrame":74},"Mean Residence Time From Time Zero to Infinity (MRT0-∞) of Propofol",{"measure":146,"description":147,"timeFrame":148},"Sedation\u002FAnesthesia Success Rate","Proportion of participants meeting the protocol-defined success criterion: MOAA\u002FS score ≤1 after anesthesia induction.","Day 1, from start of anesthesia induction until MOAA\u002FS ≤1, assessed up to 24 hours after the start of infusion.",{"measure":150,"description":151,"timeFrame":152},"Duration With Bispectral Index ≤60","Duration for which BIS is 60 or lower.","Day 1, continuously from pre-induction until 10 minutes after full recovery.",{"measure":154,"description":155,"timeFrame":152},"Total Duration With Bispectral Index 40 to 60","Cumulative duration for which BIS remains between 40 and 60.",{"measure":157,"description":158,"timeFrame":159},"Time to MOAA\u002FS Score ≤1","Time from start of anesthesia induction to the first MOAA\u002FS score ≤1.","Day 1, from start of anesthesia induction until the first MOAA\u002FS score ≤1, assessed every 20 seconds after induction up to 24 hours after the start of infusion.",{"measure":161,"description":162,"timeFrame":163},"Total Duration With MOAA\u002FS Score ≤1","Cumulative duration during which MOAA\u002FS score is ≤1.","Day 1, from induction through recovery assessments, assessed up to 24 hours after the start of infusion.",{"measure":165,"description":166,"timeFrame":167},"MOAA\u002FS Sedation Score","Sedation depth assessed using the Modified Observer's Assessment of Alertness\u002FSedation (MOAA\u002FS) scale. The scale ranges from 0 to 5, where 5 indicates responsive to normal tone of voice and 0 indicates no response to painful stimulus; higher scores indicate a more awake state.","Day 1: pre-induction; every 20 seconds after induction until MOAA\u002FS ≤1 (assessed up to 24 hours); at 5, 10, 15, 20, 30, 45 minutes and 1, 2, 3 hours after infusion start; and every 2 minutes after infusion end until 10 minutes after full recovery.",{"measure":169,"description":170,"timeFrame":171},"Modified Aldrete Score","Recovery assessed using the Modified Aldrete Score. The scale ranges from 0 to 10, where higher scores indicate better recovery; readiness to leave the recovery area requires three consecutive scores ≥9.","Day 1, every 2 minutes after full recovery until three consecutive scores ≥9, assessed up to 24 hours after the start of infusion.",{"measure":173,"description":174,"timeFrame":175},"Post-Anesthetic Discharge Scoring System Score","Discharge readiness assessed using the Post-Anesthetic Discharge Scoring System (PADSS). The scale ranges from 0 to 10, where higher scores indicate better discharge readiness; readiness for discharge requires three consecutive scores ≥9.","Day 1, every 5 minutes after three consecutive Aldrete scores ≥9 until three consecutive PADSS scores ≥9, assessed up to 24 hours after the start of infusion.",{"measure":177,"description":178,"timeFrame":179},"Time to Full Recovery","Time from end of continuous infusion to the first score of 5 in three consecutive MOAA\u002FS scores of 5.","Day 1, from end of infusion until full recovery, assessed up to 24 hours after the start of infusion.",{"measure":181,"description":182,"timeFrame":183},"Time to Recovery-Area Discharge Readiness","Time until three consecutive Modified Aldrete scores are ≥9.","Day 1, from full recovery until recovery-area discharge criteria are met, assessed up to 24 hours after the start of infusion.",{"measure":185,"description":186,"timeFrame":187},"Time to Hospital Discharge Readiness","Time until three consecutive PADSS scores are ≥9.","Day 1, from recovery-area discharge readiness until hospital discharge criteria are met, assessed up to 24 hours after the start of infusion.",{"measure":189,"description":190,"timeFrame":191},"Mini-Mental State Examination Score","Orientation and memory during recovery assessed using the Mini-Mental State Examination (MMSE). The scale ranges from 0 to 30, where higher scores indicate better cognitive function.","Day -1, and within 30 minutes, 1 hour, 2 hours, and 4 hours after discharge readiness; later assessments may stop once the result is normal.",{"measure":193,"description":194,"timeFrame":191},"Finger-to-Nose Test Result","Motor coordination during recovery assessed using the finger-to-nose test.",{"measure":196,"description":197,"timeFrame":198},"Anesthesiologist Satisfaction","Anesthesiologist satisfaction with anesthesia, assessed using the protocol-specified satisfaction assessment.","30 minutes (±10 minutes) after full recovery on Day 1.",{"measure":200,"description":201,"timeFrame":202},"Injection Site Reactions","Incidence and severity of injection-site pain, tenderness, erythema, and induration\u002Fmass.","Day 1: pre-dose; 10 seconds after induction; at infusion start; 1, 2, 3 hours after start; 10 minutes after full recovery; before Day 2 discharge; and at early termination (within 6 hours after infusion end).",null,{"allocation":205,"interventionModel":206,"interventionModelDescription":203,"primaryPurpose":6,"observationalModel":203,"timePerspective":203,"maskingInfo":207},"RANDOMIZED","PARALLEL",{"masking":208,"maskingDescription":203,"whoMasked":209},"TRIPLE",[210,211,212],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a single-center, randomized, blinded, active-controlled Phase 1 study in 30 healthy Chinese adults. The study contains three sequential cohorts defined by anesthesia-maintenance duration: 1 hour, 2 hours, and 3 hours. Each cohort will enroll approximately 10 participants. Within each cohort, participants will be randomized 4:1 to the investigational-maintenance regimen or the active-control-maintenance regimen.\n\nAll participants will receive propofol injectable emulsion 2 mg\u002Fkg intravenously over 1 minute (±5 seconds) for anesthesia induction. Maintenance infusion will begin within 30 seconds after induction. Participants assigned to the investigational regimen will receive KL0011034 Injection at a recommended maintenance rate of 1.1 mg\u002Fkg\u002Fhour; the rate may be adjusted by the investigator to maintain a bispectral index (BIS) of 40 to 60 and must not exceed the protocol-defined upper limit. Participants assigned to the active comparator will receive propofol injectable emulsion at a suggested rate of 4 to 12 mg\u002Fkg\u002Fhour, adjustable to maintain BIS at 40 to 60.\n\nThe 1-hour cohort will be evaluated before the 2-hour cohort begins, and the 2-hour cohort will be evaluated before the 3-hour cohort begins. Progression requires review confirming acceptable safety and tolerability. Participants will undergo safety monitoring, serial plasma sampling for noncompartmental pharmacokinetic analysis, and pharmacodynamic and recovery assessments including MOAA\u002FS, BIS, Modified Aldrete Score, PADSS, recovery quality, and anesthesia satisfaction. The study includes screening, a 1-day baseline period, and approximately 24 hours of post-dose observation.",[215,221,227,231,235,239],{"label":216,"type":217,"description":218,"interventionNames":219},"Cohort 1: KL0011034, 1-Hour Infusion","EXPERIMENTAL","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg\u002Fkg\u002Fhour for 1 hour. The rate may be adjusted to maintain BIS 40-60 within protocol limits.",[220],"Drug: KL0011034 Injection",{"label":222,"type":223,"description":224,"interventionNames":225},"Cohort 1: Propofol, 1-Hour Infusion","ACTIVE_COMPARATOR","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by propofol injectable emulsion at 4-12 mg\u002Fkg\u002Fhour for 1 hour. The rate may be adjusted to maintain BIS 40-60.",[226],"Drug: Propofol Injectable Emulsion",{"label":228,"type":217,"description":229,"interventionNames":230},"Cohort 2: KL0011034, 2-Hour Infusion","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg\u002Fkg\u002Fhour for 2 hours. The rate may be adjusted to maintain BIS 40-60 within protocol limits.",[220],{"label":232,"type":223,"description":233,"interventionNames":234},"Cohort 2: Propofol, 2-Hour Infusion","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by propofol injectable emulsion at 4-12 mg\u002Fkg\u002Fhour for 2 hours. The rate may be adjusted to maintain BIS 40-60.",[226],{"label":236,"type":217,"description":237,"interventionNames":238},"Cohort 3: KL0011034, 3-Hour Infusion","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by KL0011034 Injection at a recommended maintenance rate of 1.1 mg\u002Fkg\u002Fhour for 3 hours. The rate may be adjusted to maintain BIS 40-60 within protocol limits.",[220],{"label":240,"type":223,"description":241,"interventionNames":242},"Cohort 3: Propofol, 3-Hour Infusion","Participants receive propofol injectable emulsion 2 mg\u002Fkg IV for induction, followed by propofol injectable emulsion at 4-12 mg\u002Fkg\u002Fhour for 3 hours. The rate may be adjusted to maintain BIS 40-60.",[226],[244,249],{"type":245,"name":246,"description":247,"armGroupLabels":248,"otherNames":203},"DRUG","KL0011034 Injection","Intravenous maintenance infusion at a recommended rate of 1.1 mg\u002Fkg\u002Fhour for 1, 2, or 3 hours according to assigned cohort. The investigator may adjust the rate to maintain BIS 40-60; any upward adjustment must remain within the protocol-defined maximum rate of 2.5 mg\u002Fkg\u002Fhour.",[216,228,236],{"type":245,"name":250,"description":251,"armGroupLabels":252,"otherNames":203},"Propofol Injectable Emulsion","All participants receive 2 mg\u002Fkg intravenously over 1 minute (±5 seconds) for anesthesia induction. In active-comparator arms, maintenance propofol is infused at a suggested rate of 4-12 mg\u002Fkg\u002Fhour for 1, 2, or 3 hours according to assigned cohort, adjustable to maintain BIS 40-60.",[222,232,240],[254],{"name":255,"role":256,"phone":257,"phoneExt":203,"email":258},"Jie Huang","CONTACT","+86 731 8991 8665","cellahuang1988@163.com",{"type":260,"investigatorFullName":261,"investigatorTitle":262,"investigatorAffiliation":5,"oldNameTitle":203,"oldOrganization":203},"PRINCIPAL_INVESTIGATOR","Guoping Yang","Professor of Clinical Pharmacology",[264,267],{"name":265,"class":266},"Hunan Kelun Pharmaceutical Co., Ltd.","INDUSTRY",{"name":268,"class":266},"Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.","100657771","phase-1-safety-pharmacokinetics-and-pharmacodynamics-of-continuous-kl0011034-infusion-in-healthy-chinese-adults-100657771",false,"NCT07841626","Safety, Pharmacokinetics, and Pharmacodynamics of Continuous KL0011034 Infusion in Healthy Chinese Adults","A Single-Center, Randomized, Double-Blind, Active-Controlled Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Continuous Infusion of KL0011034 Injection in Healthy Chinese Adults","Inclusion Criteria:\n\n1. Participants who fully understand the purpose, content, procedures, and possible risks of the study, voluntarily agree to participate, and sign the informed consent form.\n2. Healthy male or female participants aged 18 to 45 years, inclusive, at the time of informed consent.\n3. Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index 19.0 to 26.0 kg\u002Fm², inclusive.\n4. From informed consent through 3 months after completion of study-drug infusion, the participant and partner have no reproductive plans and the participant has no sperm or egg donation plans; the participant agrees to use at least one non-pharmacologic contraceptive method through the last pharmacokinetic sample and effective contraception through 3 months after infusion.\n5. Able to communicate well with the investigator and willing and able to comply with protocol-specified lifestyle restrictions and complete study procedures.\n\nExclusion Criteria:\n\n1. Known allergy to etomidate, propofol, or other anesthetic drugs; allergic constitution (for example, allergy to two or more drugs, foods, or pollen); tendency to rash or urticaria; history of allergic disease; or known allergy to the active ingredient or excipients of KL0011034 Injection.\n2. History of clinically significant cardiovascular, endocrine, respiratory, gastrointestinal, urinary, neurologic, hematologic, lymphatic, or psychiatric disease that remains clinically significant at screening in the investigator's judgment.\n3. History of anesthesia accident, serious anesthesia-related adverse reaction, or family history of anesthesia accident.\n4. Difficult ventilation, suspected difficult airway, or anticipated difficult tracheal intubation, including Modified Mallampati Class III-IV, congenital small mouth with macroglossia, mandibular hypoplasia, or similar findings.\n5. History of airway disease before or at screening, including bronchial asthma, chronic obstructive pulmonary disease, or sleep apnea syndrome.\n6. History of adrenocortical insufficiency, adrenal tumor, hereditary disorder of heme biosynthesis, or hereditary acute porphyria.\n7. Clinically significant abnormal findings in physical examination, vital signs, posteroanterior chest radiograph, abdominal ultrasonography, hematology, urinalysis, blood chemistry, coagulation, or infectious-disease screening; or clinically significant abnormal overall circadian pattern of cortisol and\u002For ACTH at screening in the investigator's judgment.\n8. Clinically significant electrocardiogram abnormality at screening, including QTcF ≥450 ms in males or ≥460 ms in females.\n9. Pregnant or breastfeeding female, or a woman of childbearing potential with a positive pregnancy test during screening.\n10. Unprotected sexual intercourse within 2 weeks before dosing.\n11. History of drug abuse or drug dependence within 1 year before screening, or positive urine drug screen at screening.\n12. History of alcohol abuse within 6 months before screening, defined as more than 14 standard units per week (1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine); positive breath alcohol test; or unwillingness to abstain from alcohol and alcohol-containing products during the study.\n13. Smoking ≥5 cigarettes per day within 6 months before screening; unwillingness to stop using tobacco products during the study; or positive smoking test at screening.\n14. Habitual consumption of more than 8 cups per day (1 cup = 250 mL) of tea, coffee, or caffeine-containing beverages, or unwillingness to abstain from these beverages during the study.\n15. Consumption of grapefruit-rich foods or beverages within 48 hours before first dosing.\n16. Use of any prescription drug, over-the-counter drug, traditional Chinese medicine, health supplement, or vitamin within 14 days before screening; or use of sedative\u002Fanalgesic or other anesthetic drugs within 5 days before first dosing.\n17. Participation in any clinical trial within 3 months before dosing, or still in the follow-up period of another trial.\n18. Receipt of an inactivated vaccine within 1 month before screening or a live\u002Fattenuated vaccine within 3 months before screening, or planned vaccination during the study.\n19. Blood loss, blood donation, blood transfusion, or receipt of blood products totaling more than 400 mL within 3 months before screening; or planned blood donation or surgery during the study or within 1 month after study completion.\n20. Surgery within 3 months before screening, incomplete recovery from surgery, or planned surgery during the study.\n21. Special dietary requirements incompatible with standardized meals, swallowing difficulty, habitual anorexia or dieting, or initiation of a markedly abnormal diet (for example, a restrictive or low-sodium diet) within 4 weeks before screening.\n22. Difficult venous access, inability to tolerate venipuncture, or history of fainting in response to blood or needles.\n23. Expected poor compliance or any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",true,"ALL","18 Years","45 Years",{"count":281,"type":282},30,"ESTIMATED","INTERVENTIONAL",[285],"PHASE1","This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of continuous intravenous infusion of KL0011034 Injection in healthy Chinese adults. Approximately 30 participants will be enrolled in three sequential infusion-duration cohorts (1, 2, and 3 hours; 10 participants per cohort). Within each cohort, participants will be randomized in a 4:1 ratio to KL0011034 Injection or active-control propofol for anesthesia maintenance. All participants will receive propofol 2 mg\u002Fkg for anesthesia induction. Safety, pharmacokinetic, pharmacodynamic, recovery, and anesthesia-satisfaction assessments will be performed through 24 hours after dosing. Progression to the next infusion-duration cohort will occur only after the preceding cohort is considered safe and tolerable.",[288,289],"Healthy Participants Study","General Anesthesia",[291,292,289,293,294,295,296],"KL0011034","Continuous Intravenous Infusion","Pharmacokinetics","Pharmacodynamics","Bispectral Index","Healthy Participants","NOT_YET_RECRUITING","2026-09-21",{"date":300,"type":301},"2026-09-25","ACTUAL",{"date":303,"type":282},"2026-11-06",{"date":305,"type":282},"2027-09-05",{"name":5,"class":6}]