A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
2026年9月17日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Wei Qi
- 電話番号：028-82339360
- メール：qiw@kelun.com
研究場所
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Hunan
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Changsha、Hunan、中国、410205
- The Third XIANGYA Hospital of Central South University
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コンタクト：
- Guoping Yang
- 電話番号：13974817168
- メール：ygp9880@163.com
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コンタクト：
- Saiying Wang
- 電話番号：0731-88618150
- メール：1771303488@qq.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
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|
実験的：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of reported Adverse Events
時間枠：24 hours post-dose
|
Safety and tolerability was assessed by the number of volunteers with adverse events.
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24 hours post-dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PK parameter Cmax in plasma
時間枠：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
時間枠：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
時間枠：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
|
24 hours post-dose
|
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PK parameter AUC0-∞ in plasma
時間枠：24 hours post-dose
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AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
|
24 hours post-dose
|
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PK parameter t1/2 in plasma
時間枠：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
|
|
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
時間枠：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.
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Day 1
|
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Electroencephalogram bispectrality index (BIS) monitoring
時間枠：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
時間枠：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.
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Day 1
|
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Post-Anesthetic Discharge Scoring System
時間枠：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
時間枠：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
時間枠：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.
|
Day 1
|
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Anesthesia satisfaction
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月13日
一次修了 (推定)
2026年11月13日
研究の完了 (推定)
2026年11月13日
試験登録日
最初に提出
2026年9月11日
QC基準を満たした最初の提出物
2026年9月17日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18日
QC基準を満たした最後の更新が送信されました
2026年9月17日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- KL0011034-103
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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