A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects

NCT07828470 | Not Yet Recruiting Phase 1

• 1 other identifier: KL0011034-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of reported Adverse Events

  Safety and tolerability was assessed by the number of volunteers with adverse events.

  24 hours post-dose

Secondary Outcomes (12)

• PK parameter Cmax in plasma

  24 hours post-dose

• PK parameter Tmax in plasma

  24 hours post-dose

• PK parameter AUC0-t in plasma

  24 hours post-dose

• PK parameter AUC0-∞ in plasma

  24 hours post-dose

• PK parameter t1/2 in plasma

  24 hours post-dose

Study Arms (3)

Low-dose group

EXPERIMENTAL

subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for low-dose group is 1 hour (+5 min).

Drug: KL0011034 injection; Drug: propofol injectable emulsion

Medium-dose group

EXPERIMENTAL

subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for medium-dose group is 2 hours (+5 min).

Drug: KL0011034 injection; Drug: propofol injectable emulsion

High-dose group

EXPERIMENTAL

subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for high-dose group is 3 hours (+5 min).

Drug: KL0011034 injection; Drug: propofol injectable emulsion

Interventions

KL0011034 injection DRUG

Intravenous injection, continuous infusion

High-dose group; Low-dose group; Medium-dose group

propofol injectable emulsion DRUG

Intravenous injection, continuous infusion

High-dose group; Low-dose group; Medium-dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form
• Health participants (Age: 18\~45 years);
• Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2;
• There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;
• Agreed to use contraception for 3 months post-dose.

You may not qualify if:

• Allergy or Drug hypersensitivity;
• Clinically significant Medical History;
• History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
• Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
• History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
• History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
• History of any surgery within 3 months;
• History of any Medication within 14 days;
• History of any clinical study within 3 months;
• History of any vaccine within 1 month;
• History of any drug abuse;
• Needle sickness, Hematosickness;
• Massive blood loss (\> 400 mL) in the past 3 months;
• Female volunteers are pregnant or lactating;
• History of unprotected sex within 2 weeks;

Sponsors & Collaborators

• Hunan Kelun Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third XIANGYA Hospital of Central South University

Changsha, Hunan, 410205, China

Location

Central Study Contacts

Wei Qi

CONTACT

028-82339360; qiw@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)