CompletedNCT01970072Updated Jan 31, 2018

A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

A Phase 1 interventional study of Remimazolam Tosylate and Midazolam in Healthy, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-31.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 79
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers

Conditions studied

Healthy

Keywords

Remimazolam Tosylate
Phase Ⅰ study
Health

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy males or females
Weight range 50 to 100 kg inclusive
Body mass index (BMI) 18 to 26 kg/m2

Exclusion criteria

Exclusion Criteria:

Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated
With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor
Has known or suspected history of alcoholism or drug abuse or misuse within 6 months of Screening or evidence of tolerance or physical dependence before dosing with study drug
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)
Pregnant,lactating
Mallampati score ≥3

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 79 participants (actual)

Study arms

Experimental
1.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
2.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
3.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
4.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
5.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
6.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
7.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
8.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
9.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight
Drug: Remimazolam Tosylate
Experimental
10.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight
Drug: Remimazolam Tosylate
Active comparator
11.Midazolam
Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight
Drug: Midazolam

Interventions

DrugRemimazolam Tosylate
DrugMidazolam

What researchers measure

Primary outcomes

To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
Time frame: Pre-dose to 8 hours post-dosee
Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments
Time frame: Pre-dose to 2 hours post-dose
Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test
Time frame: Pre-dose to 24 hours post-dose

Study locations

1 site

Peking Union Medical College Hospital
Beijing, 100032, China

References and documents

Publications

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. PubMed 32178858 ↗
Zhou Y, Hu P, Huang Y, Nuoer S, Song K, Wang H, Wen J, Jiang J, Chen X. Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects. Front Pharmacol. 2018 Nov 19;9:1316. doi: 10.3389/fphar.2018.01316. eCollection 2018. Erratum In: Front Pharmacol. 2019 Mar 19;10:251. doi: 10.3389/fphar.2019.00251. PubMed 30510509 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01970072
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Oct 25, 2013
Start date: Oct 14, 2013
Primary completion: Jun 20, 2014
Completion: Jun 20, 2014
Last update: Jan 31, 2018

Study contacts

Bei Hu, Professor

principal investigator · Peiking Union Medical College Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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