Overview
The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants. The main questions it aims to answer are:
What are the key pharmacokinetic parameters of remimazolam, including peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and elimination half-life (T1/2)? What is the effect of remimazolam on consciousness, as measured by the MOAA/S scale and Narcotrend monitoring during anesthesia? Researchers will compare the pharmacokinetic and pharmacodynamic effects of remimazolam to see if the drug provides consistent and predictable sedation without significant adverse effects.
Participants will:
Receive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters.
Be monitored for consciousness and sedation levels using the MOAA/S scale and Narcotrend.
Undergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study.
This study will help determine the drug's behavior in the body and its impact on sedation, providing valuable information for its future clinical use in anesthesia and other medical applications.
Last updated on December 22, 2024
Eligibility
Inclusion Criteria Signed informed consent
Age ≥18 years and <65 years
Chronic renal failure scheduled for renal transplantation
Body mass index (BMI) 18-30 kg/m² (inclusive)
Weight ≥50 kg (males) or ≥45 kg (females)
ASA physical status classification III or IV
Exclusion Criteria Hepatic, psychiatric, or neurological disorders
Coagulopathy
Heart failure
Respiratory failure
Long-term sedative or antidepressant use
Pregnancy or lactation
Inability to communicate or cooperate
Participation in other drug/device trials within 3 months prior
Positive hepatitis B surface antigen (HBsAg)
Positive hepatitis C antibody (HCV-Ab)
Positive HIV antibody
Positive syphilis antibody
Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1)
Known hypersensitivity to ≥2 substances
Alcohol consumption >14 units/week within 6 months prior*
Drug abuse history within 3 months prior
Major infection/trauma within 1 month prior
Gastrointestinal surgery affecting drug absorption within 1 month prior
Vaccination within 1 month prior or planned during study
Blood loss/donation >400 mL within 3 months prior
Blood transfusion within 1 month prior
INR >1.5, PT >ULN+4 seconds, or APTT >15×ULN
Significant bleeding history within 3 months prior
Current anticoagulant therapy
Any condition deemed unsuitable by investigator