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

2026년 9월 17일 업데이트: Hunan Kelun Pharmaceutical Co., Ltd.

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

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.

연구 개요

상세 설명

This study is a randomized, double-blind, active-controlled, continuous-infusion trial. It is planned to enroll 30 healthy subjects, who will be divided into three continuous-infusion groups (Groups 1 to 3), with 10 subjects per group. Block randomization will be used to assign subjects in a 4:1 ratio to either the test drug group or the active control group. In the test drug group, subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection during the anesthesia maintenance phase. In the active control group, subjects will receive propofol injectable emulsion 2 mg/kg during induction and propofol emulsion injection during maintenance. The maintenance durations for Groups 1, 2, and 3 are 1 hour (+5 min), 2 hours (+5 min), and 3 hours (+5 min), respectively. During the study, subjects will undergo assessments of safety, tolerability, and pharmacodynamics, and blood samples will be collected for pharmacokinetic analysis.

연구 유형

중재적

등록 (추정된)

30

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Wei Qi
  • 전화번호: 028-82339360
  • 이메일: qiw@kelun.com

연구 장소

    • Hunan
      • Changsha, Hunan, 중국, 410205
        • The Third XIANGYA Hospital of Central South University
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

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예

설명

Inclusion Criteria:

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

Exclusion Criteria:

  1. Allergy or Drug hypersensitivity;
  2. Clinically significant Medical History;
  3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
  4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
  5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
  6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
  7. History of any surgery within 3 months;
  8. History of any Medication within 14 days;
  9. History of any clinical study within 3 months;
  10. History of any vaccine within 1 month;
  11. History of any drug abuse;
  12. Needle sickness, Hematosickness;
  13. Massive blood loss (> 400 mL) in the past 3 months;
  14. Female volunteers are pregnant or lactating;
  15. History of unprotected sex within 2 weeks;
  16. Heavy smoker ( more than 5 cigarettes/day) within 3 months;
  17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
  18. Heavy caffeine intake;
  19. History of grapefruit, xanthine-rich foods intake within 48 hours;
  20. Positive alcohol test;
  21. Positive nicotine test;
  22. Positive drugs of abuse test result.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Low-dose group
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).
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
실험적: Medium-dose group
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).
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
실험적: High-dose group
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).
Intravenous injection, continuous infusion
Intravenous injection, continuous infusion

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of reported Adverse Events
기간: 24 hours post-dose
Safety and tolerability was assessed by the number of volunteers with adverse events.
24 hours post-dose

2차 결과 측정

결과 측정
측정값 설명
기간
PK parameter Cmax in plasma
기간: 24 hours post-dose
Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter Tmax in plasma
기간: 24 hours post-dose
Time of Cmax (Tmax) of KL0011034 and its metabolite
24 hours post-dose
PK parameter AUC0-t in plasma
기간: 24 hours post-dose
Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite
24 hours post-dose
PK parameter AUC0-∞ in plasma
기간: 24 hours post-dose
AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
24 hours post-dose
PK parameter t1/2 in plasma
기간: 24 hours post-dose
Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite
24 hours post-dose
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
기간: Day 1
MOAA/S is a commonly used clinical sedation assessment scale, ranging from 0 to 5, which helps clinicians determine the level of sedation in patients. A score of 5 indicates full consciousness, whereas a score of 0 indicates deep coma. Lower scores correspond to deeper levels of sedation.
Day 1
Electroencephalogram bispectrality index (BIS) monitoring
기간: Day 1
BIS is the most widely used method for the continuous monitoring of sedation depth in clinical anesthesia. BIS values range from 0 to 100, where 100 represents complete wakefulness and 0 indicates complete cortical electrical inhibition.
Day 1
Modified Aldrete Scoring (Aldrete) Scale
기간: Day 1
The Modified Aldrete Score is the most widely used standardized tool for assessing discharge readiness from post-anesthesia care unit (PACU). It evaluates five parameters: activity, respiration, blood pressure consciousness, and SpO₂. Ranging from 0 to 10, the higher the score, the better the quality of recovery.
Day 1
Post-Anesthetic Discharge Scoring System
기간: Day 1
PADSS assesses based on five dimensions: vital signs, activity status, nausea and vomiting, pain severity, and surgical bleeding. Each item is scored from 0 to 2, with a total score of 10, the higher the score, the better the quality of recovery. Discharge can be arranged when the score reaches 9.
Day 1
The time of complete awakening
기간: Day 1
The definition of complete awakening is that the MOAA/S score is 5 for three consecutive times. The time point when the first score among the three consecutive times is 5 is the time point of complete awakening.
Day 1
Mini-Mental State Examination
기간: Day 1
The quality of awakening was evaluated through the "orientation in the recovery period" and "memory" sections of the MMSE scale. The "orientation in the recovery period" assesses based on 10 questions, each question is scored from 0 to 1, with a total score of 10. The "memory" assesses based on 3 questions, including the repetition of 6 different things and performing 5 subtraction calculations, with a total score of 11. the higher the score, the better the quality of awakening.
Day 1
Anesthesia satisfaction
기간: Day 1

satisfaction of anesthesiologists and satisfaction of patients. The "satisfaction of patients" assesses based on 2 parts, with a total score of 150. the higher the score, the better the quality of recovery. Part A: How do you feeling in the past 24 hours ( including 10 questions, each question is scored from 0 to 10, with a total score of 100 ). Part B: Have you experienced following 5 situations in the past 24 hours ( each situation is scored from 0 to 10, with a total score of 50 ).

The " satisfaction of anesthesiologists" assesses based on 2 dimensions: Maintaining hemodynamic stability during the maintenance period, and Awakening status (whether agitated, choking, or coughing). Each item is scored from 1 to 5, with a total score of 10, the higher the score, the better the quality of recovery.

Day 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 13일

기본 완료 (추정된)

2026년 11월 13일

연구 완료 (추정된)

2026년 11월 13일

연구 등록 날짜

최초 제출

2026년 9월 11일

QC 기준을 충족하는 최초 제출

2026년 9월 17일

처음 게시됨 (실제)

2026년 9월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • KL0011034-103

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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아니

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