- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07828470
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
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
연구 개요
상세 설명
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Wei Qi
- 전화번호: 028-82339360
- 이메일: qiw@kelun.com
연구 장소
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Hunan
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Changsha, Hunan, 중국, 410205
- The Third XIANGYA Hospital of Central South University
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연락하다:
- Guoping Yang
- 전화번호: 13974817168
- 이메일: ygp9880@163.com
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연락하다:
- Saiying Wang
- 전화번호: 0731-88618150
- 이메일: 1771303488@qq.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Heavy smoker ( more than 5 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 48 hours;
- Positive alcohol test;
- Positive nicotine test;
- Positive drugs of abuse test result.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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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).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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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).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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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).
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Intravenous injection, continuous infusion
Intravenous injection, continuous infusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of reported Adverse Events
기간: 24 hours post-dose
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Safety and tolerability was assessed by the number of volunteers with adverse events.
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24 hours post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PK parameter Cmax in plasma
기간: 24 hours post-dose
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Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter Tmax in plasma
기간: 24 hours post-dose
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Time of Cmax (Tmax) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-t in plasma
기간: 24 hours post-dose
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Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter AUC0-∞ in plasma
기간: 24 hours post-dose
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AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
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24 hours post-dose
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PK parameter t1/2 in plasma
기간: 24 hours post-dose
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Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite
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24 hours post-dose
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Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
기간: Day 1
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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.
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Day 1
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Electroencephalogram bispectrality index (BIS) monitoring
기간: Day 1
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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.
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Day 1
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Modified Aldrete Scoring (Aldrete) Scale
기간: Day 1
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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.
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Day 1
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Post-Anesthetic Discharge Scoring System
기간: Day 1
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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.
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Day 1
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The time of complete awakening
기간: Day 1
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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.
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Day 1
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Mini-Mental State Examination
기간: Day 1
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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.
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Day 1
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Anesthesia satisfaction
기간: Day 1
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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