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NOT YET RECRUITING
NCT07828470
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

KL0011034 injection

Intravenous injection, continuous infusion

DRUG

propofol injectable emulsion

Intravenous injection, continuous infusion

Locations (1)

The Third XIANGYA Hospital of Central South University

Changsha, Hunan, China