A Trial of HR18034 in Inguinal Hernia Repair

Phase 1

• Conditions: Inguinal Hernia Repair
• Interventions: Drug: HR18034; Drug: Naropin

• Registration Number: NCT04551924
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-16
• Last Update Posted: 2020-09-16
• Study Start: 2020-10-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose 3	HR18034	HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
dose 4	HR18034	HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
dose 1	HR18034	HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
dose 2	HR18034	HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
Naropin	Naropin	Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial

Primary Outcome Measures

Name	Time	Method
Number of SAEs and treatment-related severe AEs	14 days	Safety and tolerability:

Secondary Outcome Measures

Name	Time	Method
Pain intensity assessed using an 11-point NPRS ranging	Baseline till 168 hours post IP administration	11-point Numercal Pain Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NPRS of 0 or 1. Worst imaginable pain defined as an NPRS of 10
PK AUC	Baseline till 168 hours post IP administration	Area under the blood concentration-time curve (AUC)
Patient Global Assessment of the method of pain control	24 hours post IP administration till 168 hours post IP administration	Patient Global Assessment ranging from a score of 0 to 10. Satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0.
Proportion of subjects who used no rescue opioid analgesic	Baseline till 168 hours post IP administration	Proportion of subjects who used no rescue opioid analgesic
Proportion of pain-free subjects at scheduled timepoints.	Baseline till 168 hours post IP administration	Pain-free defined as an NPRS of 0 or 1
AUC of NPRS	For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours	AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Average daily rescue analgesic consumption	Baseline till 168 hours post IP administration	Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours
PK Cmax	Baseline till 168 hours post IP administration	Maximum blood concentration (Cmax)
Wound assessment by Wound healing and status score	Day 1 through Day 14	The surgical site will be examined by the investigator using Wound healing and status score. Wound healing and status score ranging from a score of 0 to 4，Good defined as a scale of 0. Worst defined as a scale of 4.
Time to the first postoperative use of rescue opioid analgesics	Baseline till 168 hours post IP administration	Time to the first postoperative use of rescue opioid analgesics

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China