A Trial of HR18034 in Inguinal Hernia Repair

NCT04551924 | Unknown Phase 1

• 1 other identifier: HR18034-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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®

Conditions

Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Number of SAEs and treatment-related severe AEs

  Safety and tolerability:

  14 days

Secondary Outcomes (10)

• Pain intensity assessed using an 11-point NPRS ranging

  Baseline till 168 hours post IP administration

• 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

  24 hours post IP administration till 168 hours post IP administration

• Proportion of pain-free subjects at scheduled timepoints.

  Baseline till 168 hours post IP administration

• Proportion of subjects who used no rescue opioid analgesic

  Baseline till 168 hours post IP administration

Study Arms (5)

dose 1

EXPERIMENTAL

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

Drug: HR18034

dose 2

EXPERIMENTAL

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

Drug: HR18034

dose 3

EXPERIMENTAL

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

Drug: HR18034

dose 4

EXPERIMENTAL

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

Drug: HR18034

Naropin

ACTIVE COMPARATOR

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

Drug: Naropin

Interventions

HR18034 DRUG

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

Also known as: subjects will receive HR18034.

dose 1; dose 2; dose 3; dose 4

Naropin DRUG

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

Also known as: Naropin, 0.5% Injectable Solution

Naropin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Mi, PhD

CONTACT

010-66937116; wwdd1962@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

CN (1)