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NOT YET RECRUITING
NCT07841626
PHASE1

Safety, Pharmacokinetics, and Pharmacodynamics of Continuous KL0011034 Infusion in Healthy Chinese Adults

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-11-06

Completion Date

2027-09-05

Last Updated

2026-09-25

Healthy Volunteers

Yes

Interventions

DRUG

KL0011034 Injection

Intravenous 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.

DRUG

Propofol Injectable Emulsion

All 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.