Safety, Pharmacokinetics, and Pharmacodynamics of Continuous KL0011034 Infusion in Healthy Chinese Adults
Summary
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.
Timeline
- Start
- 2026-11-06
- Primary completion
- 2027-09-05
- Completion
- 2027-09-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KL0011034 | Unknown | 1.1 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 2 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 4 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 12 mg/kg | Intravenous |
Indications
No indication recorded.