A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

NCT ID: NCT03444480

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-23
• Study Completion Date: 2014-08-16

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

Detailed Description

1. Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

2. Study the reversal effect and time required of Flumazepine on Rimazolam'effect.

3. Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remimazolam Tosylate 1

IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start， 0.5 mg Flumazenil is administered

Group Type: EXPERIMENTAL

Remimazolam Tosylate

Intervention Type: DRUG

Initial dose plus supplemental doses

Remimazolam Tosylate 2

IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start time,0.5ml placebo is administered

Group Type: EXPERIMENTAL

Remimazolam Tosylate

Intervention Type: DRUG

Initial dose plus supplemental doses

Interventions

Remimazolam Tosylate

Initial dose plus supplemental doses

Intervention Type: DRUG

Other Intervention Names

HR7056

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 and ≤55 years.
• Weight range 50 to 100 kg and body mass index (BMI) 18 to 26 kg/m2.
• Willing and able to comply with the requirements of the protocol.
• Provide written informed consent to participate in the study.

Exclusion Criteria

• Abnormal results of physical or laboratory examination with clinical significance
• With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV).
• With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor.
• Subject with clinically significant abnormalities in baseline 12-lead electrocardiogram (ECG) or vital signs（SBP <90 mmHg or >140 mmHg，DBP <50 mmHg or >90 mmHg；Hr <50 bpm or >100 bpm；SpO2 <95%）.
• Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated.
• Receipt of other medication within 14 days of the first study day.
• Blood donation greater than 200 ml or participation in a clinical study of an unlicensed drug in the previous 3 months.
• History of smoking or alcohol abuse within 6 months of screening.
• History of grapefruit juice or any other foods affect the activity of cytochrome P450 3A4（CYP3A4） within 7 days of screening.
• Pregnant,lactating.
• Mallampati score ≥3.
• Patients who in the opinion of the investigator may not be able to comply with the requirements of the study are not eligible

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei Hu

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Chen X, Sang N, Song K, Zhong W, Wang H, Jiang J, Huang Y, Hu P. Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote. Clin Ther. 2020 Apr;42(4):614-624. doi: 10.1016/j.clinthera.2020.02.006. Epub 2020 Mar 13.

Reference Type: DERIVED

PMID: 32178858 (View on PubMed)

Other Identifiers

RMZL-PIb

Identifier Type: -

Identifier Source: org_study_id