Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)Phase 2NCT04867343
Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
A Phase 2 study testing HR020602 injection and fentanyl injection ； remifentanil injection in people with Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)
- What is being tested?
- HR020602 injection and fentanyl injection ； remifentanil injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2021to 15 Aug 2023
- Phase
- Phase 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2 years old ≤age<18 years old, regardless of gender;
- General anesthesia is planned;
- ASA score grade I ~ II; 4）Able to sign the informed consent.
Who cannot join
- Children with general anesthesia contraindications;
- With diseases that are not suitable for the study in the scheme;
- Abnormal liver and kidney function in screening stage;
- Abnormal coagulation function;
- Serum electrolyte abnormality;
- Subjects intolerant or allergic to the study drugs;
- Recently received other narcotic drugs or other drugs that affect the metabolism of study drugs;
- The child thought to be unsuitable for the study, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, 300052
About this study
This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of [2,12] and [12,18）age groups.
- Being tested
- HR020602 injection, fentanyl injection ； remifentanil injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR020602 injectionDrug
HR020602 injection
fentanyl injection ； remifentanil injectionDrug
fentanyl injection + remifentanil injection
| Study group | Role | What they receive |
|---|---|---|
| HR020602 injection | Experimental | Not described Receives: Drug: HR020602 injection |
| fentanyl injection + remifentanil injection | Active comparator | Not described Receives: Drug: fentanyl injection ； remifentanil injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of anesthesia induction
Measured: Within 5 minutesafter propofol medium /long chain fat emulsion administration
Secondary outcomes (8)
The success rate of anesthesia maintenance
Measured: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Anesthesia recovery time
Measured: The time from stopping using anesthetic drugs (propofol medium/long-chain fat emulsion) to the time when the subject wakes up (opening eyes as instructed)
The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period
Measured: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
The dosage of opioids during anesthesia maintenance period
Measured: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Clearance rate (CL), apparent volume of distribution (V) and inter individual variation (CV%) of parameters
Measured: PK blood collection are to be performed at 5 time points during Day 1-Day 2)
The incidence and severity of adverse events during the trial
Measured: Through study completion, about 3-10 days)
The incidence of adverse reactions of the mental system
Measured: Within 1 hour after awakening)
Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
Measured: Through study completion, about 3-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start7 Jun 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification. The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of \[2,12\] and \[12,18）age groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867343
- Sponsor's protocol ID
- HR020602-201
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zou N, Wang X, Wang F, Zou X, Wang SY, Shangguan W, Lin X, Lei Q, Yu Y, Wang Z, Tang L, Ding Y, Zhang J. Efficacy and safety of HR020602 in combination with propofol in children receiving general anesthesia: a multicenter, phase 2 study. BMC Pediatr. 2026 Jan 16;26(1):164. doi: 10.1186/s12887-025-06495-7.
PubMed 41545823
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT04867343
- Acronym / sponsor ID
- HR020602-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 30 Apr 2021 (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.
This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of [2,12] and [12,18）age groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification. The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of [2,12] and [12,18）age groups.
| Arm | Type | Receives |
|---|---|---|
| HR020602 injection | Experimental | Drug: HR020602 injection |
| fentanyl injection + remifentanil injection | Active comparator | Drug: fentanyl injection ； remifentanil injection |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 2 years old ≤age<18 years old, regardless of gender;
- General anesthesia is planned;
- ASA score grade I ~ II; 4）Able to sign the informed consent.
Key exclusion criteria (8 listed)
- Children with general anesthesia contraindications;
- With diseases that are not suitable for the study in the scheme;
- Abnormal liver and kidney function in screening stage;
- Abnormal coagulation function;
- Serum electrolyte abnormality;
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 |
|---|---|---|
| HR020602 injectionHR020602 injection | Drug | HR020602 injection |
| fentanyl injection ； remifentanil injectionfentanyl injection + remifentanil injection | Drug | fentanyl injection + remifentanil injection |
Primary outcome
The success rate of anesthesia induction
Time frame: Within 5 minutesafter propofol medium /long chain fat emulsion administration
8 secondary outcomes
The success rate of anesthesia maintenance
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Anesthesia recovery time
Time frame: The time from stopping using anesthetic drugs (propofol medium/long-chain fat emulsion) to the time when the subject wakes up (opening eyes as instructed)
The dosage of propofol medium/long chain fat emulsion during anesthesia maintenance period
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
The dosage of opioids during anesthesia maintenance period
Time frame: Procedure (During the period from the beginning of anesthesia maintenance drugs to the end of anesthesia)
Clearance rate (CL), apparent volume of distribution (V) and inter individual variation (CV%) of parameters
Time frame: PK blood collection are to be performed at 5 time points during Day 1-Day 2)
The incidence and severity of adverse events during the trial
Time frame: Through study completion, about 3-10 days)
The incidence of adverse reactions of the mental system
Time frame: Within 1 hour after awakening)
Proportion of subjects with unstable hemodynamics (blood pressure, heart rate)
Time frame: Through study completion, about 3-10 days)
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 4 Mar 2024.
- Derived from this study: PubMed 41545823Zou N, Wang X, Wang F, Zou X, Wang SY, Shangguan W, Lin X, Lei Q, Yu Y, Wang Z, Tang L, Ding Y, Zhang J. Efficacy and safety of HR020602 in combination with propofol in children receiving general anesthesia: a multicenter, phase 2 study. BMC Pediatr. 2026 Jan 16;26(1):164. doi: 10.1186/s12887-025-06495-7.
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 2 study testing HR020602 injection and fentanyl injection ； remifentanil injection in people with Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol), 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 8 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 4 Mar 2024. 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 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?
The success rate of anesthesia induction (time frame: Within 5 minutesafter propofol medium /long chain fat emulsion administration). 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 NCT04867343, which also lists 1 linked publication.
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 4 Mar 2024.