A Trial of HR18034 in Inguinal Hernia Repair

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair

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

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia Repair
• Intervention / Treatment: Drug: Naropin; Drug: HR18034

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Weidong Mi, PhD; Phone Number: 010-66937116; Email: wwdd1962@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: dose 1; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome	Drug: HR18034; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome; Other Names: subjects will receive HR18034.
EXPERIMENTAL: dose 2; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome	Drug: HR18034; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome; Other Names: subjects will receive HR18034.
EXPERIMENTAL: dose 3; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome	Drug: HR18034; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome; Other Names: subjects will receive HR18034.
EXPERIMENTAL: dose 4; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome	Drug: HR18034; HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome; Other Names: subjects will receive HR18034.
ACTIVE_COMPARATOR: Naropin; Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial	Drug: Naropin; Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL; Other Names: Naropin, 0.5% Injectable Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SAEs and treatment-related severe AEs	Safety and tolerability:	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity assessed using an 11-point NPRS ranging	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	Baseline till 168 hours post IP administration
AUC of NPRS	AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours	For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Patient Global Assessment of the method of pain control	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.	24 hours post IP administration till 168 hours post IP administration
Proportion of pain-free subjects at scheduled timepoints.	Pain-free defined as an NPRS of 0 or 1	Baseline till 168 hours post IP administration
Proportion of subjects who used no rescue opioid analgesic	Proportion of subjects who used no rescue opioid analgesic	Baseline till 168 hours post IP administration
Average daily rescue analgesic consumption	Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours	Baseline till 168 hours post IP administration
Time to the first postoperative use of rescue opioid analgesics	Time to the first postoperative use of rescue opioid analgesics	Baseline till 168 hours post IP administration
PK Cmax	Maximum blood concentration (Cmax)	Baseline till 168 hours post IP administration
Wound assessment by Wound healing and status score	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.	Day 1 through Day 14
PK AUC	Area under the blood concentration-time curve (AUC)	Baseline till 168 hours post IP administration

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): May 30, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HR18034-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No