Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Used to Induce and Implement General Anesthesia in Combination With Sedative Anesthetics (Such as Propofol)

Treatments: Drug: HR020602 injection; Drug: fentanyl injection ； remifentanil injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04867343

HR020602-201

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 2 years old ≤age<18 years old, regardless of gender;
2. General anesthesia is planned;
3. ASA score grade I ~ II; 4）Able to sign the informed consent.

Exclusion criteria

1. Children with general anesthesia contraindications;
2. With diseases that are not suitable for the study in the scheme;
3. Abnormal liver and kidney function in screening stage;
4. Abnormal coagulation function;
5. Serum electrolyte abnormality;
6. Subjects intolerant or allergic to the study drugs;
7. Recently received other narcotic drugs or other drugs that affect the metabolism of study drugs;
8. The child thought to be unsuitable for the study, as determined by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

HR020602 injection

Experimental group

Treatment:

Drug: HR020602 injection

fentanyl injection + remifentanil injection

Active Comparator group

Treatment:

Drug: fentanyl injection ； remifentanil injection