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Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose 1 | Experimental | HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome |
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| dose 2 | Experimental | HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome |
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| dose 3 | Experimental | HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome |
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| dose 4 | Experimental | HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome |
|
| Naropin | Active Comparator | Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034 | Drug | HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of SAEs and treatment-related severe AEs | Safety and tolerability: | 14 days |
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Mi, PhD | Contact | 010-66937116 | wwdd1962@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Mi, PhD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100039 | China |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
| 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 |
|
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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 |
| D000588 |
| Amines |