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/kg 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.
Participants who fully understand the purpose, content, procedures, and possible risks of the study, voluntarily agree to participate, and sign the informed consent form.
Healthy male or female participants aged 18 to 45 years, inclusive, at the time of informed consent.
Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index 19.0 to 26.0 kg/m², inclusive.
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.
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.
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.
History of anesthesia accident, serious anesthesia-related adverse reaction, or family history of anesthesia accident.
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.
Parallel
KL0011034 Injection
DrugIntravenous maintenance infusion at a recommended rate of 1.1 mg/kg/hour 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/kg/hour.
Propofol Injectable Emulsion
DrugAll participants receive 2 mg/kg 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/kg/hour for 1, 2, or 3 hours according to assigned cohort, adjustable to maintain BIS 40-60.
6
Treatment groupsSee each treatment group below.
Adverse Events and Serious Adverse Events
Incidence, severity, seriousness, relationship, and outcome of adverse events and serious adverse events.
Physical Examination Findings
Number of participants with clinically significant changes or abnormalities in physical examination findings.
Holter Monitoring Findings
Clinically significant abnormalities detected by protocol-specified Holter monitoring.
Plasma Cortisol Concentration
Plasma cortisol concentration (measured in nmol/L) assessed by protocol-specified laboratory testing.
Maximum Plasma Concentration (Cmax) of KL0011034
Maximum observed plasma concentration.
Time to Maximum Plasma Concentration (Tmax) of KL0011034
Time of the first occurrence of the maximum observed plasma concentration.
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of KL0011034
Calculated using the linear-up/log-down trapezoidal method.
Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of KL0011034
Calculated as AUC0-t + Clast/λz.
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The Third Xiangya Hospital of Central South University
Lead sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Collaborator
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Collaborator
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