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A Trial of HR18034 in Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia Repair

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HR18034

Naropin

About this trial

This is an interventional supportive care trial for Inguinal Hernia Repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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:

Clinically significant abnormal clinical laboratory test value
Subjects with poor blood pressure control after medication
Subjects with atrioventricular block or cardiac insufficiency
Subjects with a history of myocardial infarction or unstable angina pectoris
Subjects with a history of ischemic stroke or transient ischemic attack
Combination of other pain conditions that may affect postoperative pain assessment
Allergic to a drug ingredient or component
Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
Subjects with special diets (including tobacco, grapefruit and caffeine)
Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B.
Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:
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
Participated in clinical trials of other drugs (received experimental drugs)
History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
Pregnant or nursing women
No birth control during the specified period of time
The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Sites / Locations

Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

dose 1

dose 2

dose 3

dose 4

Naropin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of SAEs and treatment-related severe AEs

Safety and tolerability:

Secondary Outcome Measures

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

AUC of NPRS

AUC of NPRS 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.

Proportion of pain-free subjects at scheduled timepoints.

Pain-free defined as an NPRS of 0 or 1

Proportion of subjects who used no rescue opioid analgesic

Average daily rescue analgesic consumption

Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours

Time to the first postoperative use of rescue opioid analgesics

PK Cmax

Maximum blood concentration (Cmax)

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.

PK AUC

Area under the blood concentration-time curve (AUC)

Full Information

NCT ID

NCT04551924

First Posted

September 8, 2020

Last Updated

September 15, 2020

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04551924

Brief Title

A Trial of HR18034 in Inguinal Hernia Repair

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Anticipated)

Primary Completion Date

May 30, 2021 (Anticipated)

Study Completion Date

May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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®

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia Repair

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

To maintain objectiveness, the study drug will be managed and administered by an independent unblinded team. Subjects, investigators, and all other site staff who directly interact with subjects, evaluate safety and efficacy, and collect subject data, will remain blinded and must not communicate or discuss any study information with the unblinded team.

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dose 1

Arm Type

Experimental

Arm Description

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

Arm Title

dose 2

Arm Type

Experimental

Arm Description

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

Arm Title

dose 3

Arm Type

Experimental

Arm Description

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

Arm Title

dose 4

Arm Type

Experimental

Arm Description

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

Arm Title

Naropin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HR18034

Other Intervention Name(s)

subjects will receive HR18034.

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Naropin

Other Intervention Name(s)

Naropin, 0.5% Injectable Solution

Intervention Description

Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL

Primary Outcome Measure Information:

Title

Number of SAEs and treatment-related severe AEs

Description

Safety and tolerability:

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Pain intensity assessed using an 11-point NPRS ranging

Description

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

Time Frame

Baseline till 168 hours post IP administration

Title

AUC of NPRS

Description

AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours

Time Frame

For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours

Title

Patient Global Assessment of the method of pain control

Description

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.

Time Frame

24 hours post IP administration till 168 hours post IP administration

Title

Proportion of pain-free subjects at scheduled timepoints.

Description

Pain-free defined as an NPRS of 0 or 1

Time Frame

Baseline till 168 hours post IP administration

Title

Proportion of subjects who used no rescue opioid analgesic

Description

Proportion of subjects who used no rescue opioid analgesic

Time Frame

Baseline till 168 hours post IP administration

Title

Average daily rescue analgesic consumption

Description

Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours

Time Frame

Baseline till 168 hours post IP administration

Title

Time to the first postoperative use of rescue opioid analgesics

Description

Time to the first postoperative use of rescue opioid analgesics

Time Frame

Baseline till 168 hours post IP administration

Title

PK Cmax

Description

Maximum blood concentration (Cmax)

Time Frame

Baseline till 168 hours post IP administration

Title

Wound assessment by Wound healing and status score

Description

Time Frame

Day 1 through Day 14

Title

PK AUC

Description

Area under the blood concentration-time curve (AUC)

Time Frame

Baseline till 168 hours post IP administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Clinically significant abnormal clinical laboratory test value Subjects with poor blood pressure control after medication Subjects with atrioventricular block or cardiac insufficiency Subjects with a history of myocardial infarction or unstable angina pectoris Subjects with a history of ischemic stroke or transient ischemic attack Combination of other pain conditions that may affect postoperative pain assessment Allergic to a drug ingredient or component Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer History of alcohol abuse or prescription and/or illicit drug abuse within 1 years Subjects with special diets (including tobacco, grapefruit and caffeine) Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse. History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B. Use of any of the following medications within 14 days or as specified prior to the study surgical procedure: 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 Participated in clinical trials of other drugs (received experimental drugs) History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition. Pregnant or nursing women No birth control during the specified period of time The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weidong Mi, PhD

Phone

010-66937116

wwdd1962@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weidong Mi, PhD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weidong Mi, PhD

Phone

010-66937116

wwdd1962@aliyun.com

12. IPD Sharing Statement

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A Trial of HR18034 in Inguinal Hernia Repair

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