Sedation in the ICUPhase 1/2NCT05913336

A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

A Phase 1/2 study testing Remimazolam Tosilate in people with Sedation in the ICU, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sedation in the ICU
What is being tested?: Remimazolam Tosilate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 27 Jun 2023to 5 Mar 2025
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients or their guardians are able to provide a written informed consent
Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
Age ≥ 18 and ≤ 80 years, male or female
Body mass index (BMI) > 18 and < 30 kg/m2

Who cannot join

participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
Organ failure during screening period；
Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
History of epilepsy or status epilepticus;
Subjects with a history of drug abuse；

Show all 16Show fewer

Myasthenia gravis or a history of myasthenia gravis;
severe arrhythmias or heart disease;
Subjects after neurosurgery operation；
participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
Abnormal values of the laboratory examination
Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
Allergic to relevant drugs ingredient or component;
Pregnant or nursing women;
Subjects who has participated in clinical trials of other interventions recently;
Other conditions deemed unsuitable to be included.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001

Other trials in China

About this study

Official title: Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Conditions: Sedation in the ICU
Being tested: Remimazolam Tosilate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remimazolam TosilateDrug
Loading dose: 0.08mg/kg , Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h

Study groups in NCT05913336
Study group	Role	What they receive
Remimazolam Tosilate	Experimental	IV of Remimazolam Tosilate Receives: Drug: Remimazolam Tosilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Measured: within 72 hours after administration of research drug

Secondary outcomes (6)

Percentage of time maintaining target sedation in the entire drug administering time.
Measured: within 72 hours after administration of research drug
Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation
Measured: within 72 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia
Measured: within 72 hours after administration of research drug
Wake-up time.
Measured: after stopping the research drug
Evaluation of nursing difficulty.
Measured: follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.
Measured: at the time of extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 20235 Mar 2025

First posted22 Jun 2023
Study start27 Jun 2023
Primary completion5 Mar 2025
Study completion5 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedation in the ICUStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05913336
Sponsor's protocol ID: HR7056-206
Status last verified: Sep 2025
First submitted: 13 Jun 2023
Last updated: 3 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care

All Sedation in the ICU trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial
ClinicalTrials.gov ID: NCT05913336
Acronym / sponsor ID: HR7056-206
Conditions: Sedation in the ICU
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 Jun 2023 (actual)
Primary completion: 5 Mar 2025 (actual)
Study completion: 5 Mar 2025 (actual)
First posted: 22 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Remimazolam Tosilate	Experimental	Drug: Remimazolam TosilateIV of Remimazolam Tosilate

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients or their guardians are able to provide a written informed consent
Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
Age ≥ 18 and ≤ 80 years, male or female
Body mass index (BMI) > 18 and < 30 kg/m2

Key exclusion criteria (16 listed)

participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
Organ failure during screening period；
Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
History of epilepsy or status epilepticus;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remimazolam TosilateLoading dose: 0.08mg/kg , Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h	Drug	Remimazolam Tosilate

Primary outcome

Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.
Time frame: within 72 hours after administration of research drug

6 secondary outcomes

Percentage of time maintaining target sedation in the entire drug administering time.
Time frame: within 72 hours after administration of research drug
Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation
Time frame: within 72 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia
Time frame: within 72 hours after administration of research drug
Wake-up time.
Time frame: after stopping the research drug
Evaluation of nursing difficulty.
Time frame: follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.
Time frame: at the time of extubation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Individual participant dataSharing planned: Undecided

Related trials for Sedation in the ICU

Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Remimazolam Tosilate in people with Sedation in the ICU, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation. (time frame: within 72 hours after administration of research drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05913336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.