HealthyPhase 1NCT01970072
A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
A Phase 1 study testing Remimazolam Tosylate and Midazolam in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Remimazolam Tosylate and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2013to 20 Jun 2014
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females
- Weight range 50 to 100 kg inclusive
- Body mass index (BMI) 18 to 26 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam TosylateDrug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| 1.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 2.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 3.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 4.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 5.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 6.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 7.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 8.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 9.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 10.Remimazolam Tosylate | Experimental | Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight Receives: Drug: Remimazolam Tosylate |
| 11.Midazolam | Active comparator | Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
Measured: Pre-dose to 8 hours post-dosee
Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments
Measured: Pre-dose to 2 hours post-dose
Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test
Measured: Pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study start14 Oct 2013
- Primary completion20 Jun 2014
- Study completion20 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bei Hu, Professor, Principal investigator, Peiking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970072
- Sponsor's protocol ID
- RMZL-PIa
- Status last verified
- Jan 2018
- First submitted
- 22 Oct 2013
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 32178858Zhou 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.
PubMed 30510509
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate
- ClinicalTrials.gov ID
- NCT01970072
- Acronym / sponsor ID
- RMZL-PIa
- Conditions
- Healthy
- Keywords
- Remimazolam Tosylate, Phase Ⅰ study, Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2013 (actual)
- Primary completion
- 20 Jun 2014 (actual)
- Study completion
- 20 Jun 2014 (actual)
- First posted
- 25 Oct 2013 (estimated)
- 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 and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 1.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight |
| 2.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight |
| 3.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight |
| 4.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight |
| 5.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight |
| 6.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight |
| 7.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight |
| 8.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight |
| 9.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight |
| 10.Remimazolam Tosylate | Experimental | Drug: Remimazolam TosylateSingle IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight |
| 11.Midazolam | Active comparator | Drug: MidazolamSingle IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or females
- Weight range 50 to 100 kg inclusive
- Body mass index (BMI) 18 to 26 kg/m2
Key exclusion criteria (6 listed)
- 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
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 Tosylate | Drug | 1.Remimazolam Tosylate, 10.Remimazolam Tosylate, 2.Remimazolam Tosylate, 3.Remimazolam Tosylate, 4.Remimazolam Tosylate, 5.Remimazolam Tosylate, 6.Remimazolam Tosylate, 7.Remimazolam Tosylate, 8.Remimazolam Tosylate, 9.Remimazolam Tosylate |
| Midazolam | Drug | 11.Midazolam |
Primary outcome
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
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 31 Jan 2018.
- Derived from this study: PubMed 32178858Chen 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.
- Derived from this study: PubMed 30510509Zhou 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Bei Hu, Professor principal investigator
Peiking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remimazolam Tosylate and Midazolam in people with Healthy, 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 3 inclusion and 6 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 31 Jan 2018. 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 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.
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?
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). The study lists 3 primary outcomes in all. 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 NCT01970072, which also lists 2 linked publications.
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 31 Jan 2018.