A Trial of HR18034 in Inguinal Hernia Repair

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Inguinal Hernia Repair

Treatments: Drug: Naropin; Drug: HR18034

Study type: Interventional

Funder types: Industry

Identifiers

NCT04551924

HR18034-101

Details and patient eligibility

About

Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Able and willing to provide a written informed consent 2、Male or female between 18 and 70 years of age 3、Scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4、Meet the body mass 5、Conform to the ASA Physical Status Classification

Exclusion criteria

1. Clinically significant abnormal clinical laboratory test value
2. Subjects with poor blood pressure control after medication
3. Subjects with atrioventricular block or cardiac insufficiency
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with a history of ischemic stroke or transient ischemic attack
6. Combination of other pain conditions that may affect postoperative pain assessment
7. Allergic to a drug ingredient or component
8. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
9. History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
10. Subjects with special diets (including tobacco, grapefruit and caffeine)
11. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
12. History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B.
13. Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:
14. Have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically
15. Participated in clinical trials of other drugs (received experimental drugs)
16. History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
17. Pregnant or nursing women
18. No birth control during the specified period of time
19. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 5 patient groups

dose 1

Experimental group

Description:

HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome

Treatment:

Drug: HR18034

dose 2

Experimental group

Description:

HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome

Treatment:

Drug: HR18034

dose 3

Experimental group

Description:

HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome

Treatment:

Drug: HR18034

dose 4

Experimental group

Description:

HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome

Treatment:

Drug: HR18034

Naropin

Active Comparator group

Description:

Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial

Treatment:

Drug: Naropin