115563
论文已发表
注册即可获取德孚的最新动态
IF 收录期刊
- 3.6 Breast Cancer (Dove Med Press)
- 4.3 Clin Epidemiol
- 2.6 Cancer Manag Res
- 3.2 Infect Drug Resist
- 4.1 Clin Interv Aging
- 6.1 Drug Des Dev Ther
- 4.1 Int J Chronic Obstr
- 8.7 Int J Nanomed
- 2.5 Int J Women's Health
- 3.2 Neuropsych Dis Treat
- 2.4 OncoTargets Ther
- 2.6 Patient Prefer Adher
- 2.6 Ther Clin Risk Manag
- 3.1 J Pain Res
- 3.5 Diabet Metab Synd Ob
- 4.5 Psychol Res Behav Ma
- 3.4 Nat Sci Sleep
- 2.4 Pharmgenomics Pers Med
- 2.6 Risk Manag Healthc Policy
- 4.6 J Inflamm Res
- 2.3 Int J Gen Med
- 3.9 J Hepatocell Carcinoma
- 3.3 J Asthma Allergy
- 2.5 Clin Cosmet Investig Dermatol
- 3.0 J Multidiscip Healthc
已发表论文
环泊酚对健康受试者心脏除极和复极的影响：一项单中心、随机、安慰剂和阳性对照充分 QT 研究
Authors Kleiman R, Rudo T, Daley W, Hu M, Yan P, Zhou R, Hou J
Received 3 September 2025
Accepted for publication 24 December 2025
Published 14 January 2026 Volume 2026:20 565051
DOI https://doi.org/10.2147/DDDT.S565051
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Solomon Tadesse Zeleke
Robert Kleiman,1 Todd Rudo,1 William Daley,2 Mengyue Hu,3 Pangke Yan,3 Rong Zhou,3 Jie Hou4
1Cardia Safety, Clario, Philadelphia, PA, USA; 2Haisco-USA Pharmaceutical Company, Inc, Bridgewater, NJ, USA; 3Haisco Pharmaceutical Group Co. Ltd, Chengdu, People’s Republic of China; 4Phase I Center, Beijing Gobroad Boren Hospital, Beijing, People’s Republic of China
Correspondence: Jie Hou, Phase I Center, Beijing Gobroad Boren Hospital, No. 6 South Zhengwangfen, South Third Ring Road, Fengtai District, Beijing, 102200, People’s Republic of China, Tel +8618611422958, Email jie.hou@gohealtharo.com
Background: Cipepofol (HSK3486), a gamma-aminobutyric acid type A (GABAA) receptor agonist, has garnered considerable attention as a potential alternative to propofol. This study aimed to evaluate the effects of a single intravenous (IV) bolus dose of cipepofol (0.4 mg/kg) on QTc interval in healthy subjects.
Patients and Methods: This was a single-center, randomized, blinded (except for moxifloxacin), placebo- and positive-controlled study with a six-sequence, three-period crossover study. Subjects were randomized to 1 of 3 treatment groups in each period: Group A (placebo); Group B (single dose of 0.4 g moxifloxacin, positive control); and Group C (cipepofol [HSK3486], 0.4 mg/kg via IV bolus). The primary endpoint was the change-from-baseline in QTc interval, corrected for heart rate (HR) using the individual QT correction method (QTcI) – ΔQTcI. Secondary endpoints included change-from-baseline in other electrocardiographic (ECG) parameters. Safety/tolerability and pharmacokinetics of cipepofol were also assessed.
Results: Forty-eight subjects were randomized, and demographic characteristics were comparable across the six sequences. The LS mean placebo-corrected ΔQTcI (ΔΔQTcI) interval following cipepofol bolus ranged from − 1.7 to 4.1 milliseconds. The upper bound of the two-sided 90% confidence interval for ΔΔQTcI interval remained < 10 milliseconds at all post-dose timepoints. In addition, no clinically significant effects of cipepofol were observed on the PR interval or QRS interval (ventricular depolarization time). Assay sensitivity was successfully demonstrated by the expected QTc interval prolongation within 2– 4 h post-moxifloxacin administration. No subjects in the cipepofol treatment period developed a new QTcI interval > 480 or an increase in QTcI interval from baseline > 60 milliseconds. All adverse events were mild to moderate in severity, and no serious adverse events or deaths occurred.
Conclusion: Cipepofol exhibited no clinically relevant effects on the QTc interval or other ECG parameters, and was safe and well tolerated in healthy subjects.
Clinical Trial Registration: This study was registered on ClinicalTrials.gov (NCT06379867).
Keywords: cipepofol, cardiac repolarization, effect, QT/QTc interval, pharmacokinetics, safety
1Cardia Safety, Clario, Philadelphia, PA, USA; 2Haisco-USA Pharmaceutical Company, Inc, Bridgewater, NJ, USA; 3Haisco Pharmaceutical Group Co. Ltd, Chengdu, People’s Republic of China; 4Phase I Center, Beijing Gobroad Boren Hospital, Beijing, People’s Republic of China
Correspondence: Jie Hou, Phase I Center, Beijing Gobroad Boren Hospital, No. 6 South Zhengwangfen, South Third Ring Road, Fengtai District, Beijing, 102200, People’s Republic of China, Tel +8618611422958, Email jie.hou@gohealtharo.com
Background: Cipepofol (HSK3486), a gamma-aminobutyric acid type A (GABAA) receptor agonist, has garnered considerable attention as a potential alternative to propofol. This study aimed to evaluate the effects of a single intravenous (IV) bolus dose of cipepofol (0.4 mg/kg) on QTc interval in healthy subjects.
Patients and Methods: This was a single-center, randomized, blinded (except for moxifloxacin), placebo- and positive-controlled study with a six-sequence, three-period crossover study. Subjects were randomized to 1 of 3 treatment groups in each period: Group A (placebo); Group B (single dose of 0.4 g moxifloxacin, positive control); and Group C (cipepofol [HSK3486], 0.4 mg/kg via IV bolus). The primary endpoint was the change-from-baseline in QTc interval, corrected for heart rate (HR) using the individual QT correction method (QTcI) – ΔQTcI. Secondary endpoints included change-from-baseline in other electrocardiographic (ECG) parameters. Safety/tolerability and pharmacokinetics of cipepofol were also assessed.
Results: Forty-eight subjects were randomized, and demographic characteristics were comparable across the six sequences. The LS mean placebo-corrected ΔQTcI (ΔΔQTcI) interval following cipepofol bolus ranged from − 1.7 to 4.1 milliseconds. The upper bound of the two-sided 90% confidence interval for ΔΔQTcI interval remained < 10 milliseconds at all post-dose timepoints. In addition, no clinically significant effects of cipepofol were observed on the PR interval or QRS interval (ventricular depolarization time). Assay sensitivity was successfully demonstrated by the expected QTc interval prolongation within 2– 4 h post-moxifloxacin administration. No subjects in the cipepofol treatment period developed a new QTcI interval > 480 or an increase in QTcI interval from baseline > 60 milliseconds. All adverse events were mild to moderate in severity, and no serious adverse events or deaths occurred.
Conclusion: Cipepofol exhibited no clinically relevant effects on the QTc interval or other ECG parameters, and was safe and well tolerated in healthy subjects.
Clinical Trial Registration: This study was registered on ClinicalTrials.gov (NCT06379867).
Keywords: cipepofol, cardiac repolarization, effect, QT/QTc interval, pharmacokinetics, safety