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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.
Summary
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the KL0011034 injection.
Official title: A Single-center, Randomized, Double-blind, Propofol Position-controlled Phase I Clinical Study Evaluating the Safety, Pharmacokinetics/Pharmacodynamics of KL0011034 Injection by Continuous Infusion in Healthy Chinese Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-13
Completion Date
2026-11-13
Last Updated
2026-09-18
Healthy Volunteers
Yes
Conditions
Interventions
KL0011034 injection
Intravenous injection, continuous infusion
propofol injectable emulsion
Intravenous injection, continuous infusion
Locations (1)
The Third XIANGYA Hospital of Central South University
Changsha, Hunan, China