Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

Phase 2 Completed 36 enrolled Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Yichang Humanwell Pharmaceutical Co., Ltd., China · collab

RandomizedParallel-groupSingle-blindOther

Summary

This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.

Timeline

Start: 2022-04-08
Primary completion: 2023-02-28
Completion: 2023-02-28

Outcome

Missed primary endpoint

paper The percentage of time with the target RASS scores without rescue sedation did not differ among the groups PMID 42164587 ↗

paper P=0.665 PMID 42164587 ↗

Publications

Yang X, Fu S, Yu L, Liang F, Li D, Sun R, Zhou X, Yu X, Tian L, Shang Y. Efficacy and safety of remimazolam besylate in patients receiving mechanical ventilation: A randomized phase Ⅱa trial. J Intensive Med. 2026 Jan 8;6(3):277-283. doi: 10.1016/j.jointm.2025.12.002. eCollection 2026 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Remimazolam	Small molecule	0.1 mg/kg	—
Subject	Remimazolam	Small molecule	0.2 mg/kg	—
Subject	Remimazolam	Small molecule	0.4 mg/kg	—

Indications

No indication recorded.