Clinical Trials Logo
  1. Home
  2. Acute Postoperative Pain
  3. NCT04169256

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers

Acute Postoperative Pain Clinical Trial

Official title:
A Phase I, Single Centre, Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose-Escalation, Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 and Liposome Bupivacaine in Healthy Volunteers

Clinical Trial Summary

This study is the first time into human study (FTIH) for HYR-PB21 for injection. The study will evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and single subcutaneous dose of HYR-PB21 for injection in healthy adult volunteers.The results of this study are intended to be used to identify appropriate and well tolerated doses of HYR-PB21 for injection to be used in further studies. A comparison of PK/PD characteristics between HYR-PB21 for injection and EXPAREL will also be included in this study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04169256
Study type Interventional
Source Fruithy Medical Pty Ltd
Contact
Status Completed
Phase Phase 1
Start date March 3, 2020
Completion date July 30, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05926817 - Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery N/A
Completed NCT05351203 - Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries N/A
Completed NCT05386095 - Axillary Brachial Plexus Block Using 0.25% Bupivacaine Versus Using 0.19%Bupivacaine in Pediatrics N/A
Completed NCT05364216 - Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients N/A
Completed NCT04875390 - Erector Spina Plane (ESP) Block in Pediatric Patients N/A
Recruiting NCT06381401 - Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults Phase 4
Completed NCT05068037 - Influence of Hypnoacupuncture on Early Perioperative Recovery N/A
Completed NCT04855240 - Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy Phase 2
Recruiting NCT06381063 - Non-steroidal Anti-inflammatory in Cardiac Surgery N/A
Completed NCT02107339 - Methadone and Hydromorphone For Spinal Surgery Phase 4
Recruiting NCT06281275 - A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients
Not yet recruiting NCT06088602 - Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty N/A
Not yet recruiting NCT04775992 - Preemptive Analgesia of Gabapentoids in Orthopedic Surgery
Active, not recruiting NCT05260008 - Study Assessing Pain Relief After Replacement of the Knee Phase 2
Completed NCT01828424 - Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery
Not yet recruiting NCT05865366 - Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients
Recruiting NCT04033471 - Combined Epidural Morphine and Midazolam on Postoperative Pain Phase 1/Phase 2
Completed NCT03903224 - Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy N/A
Completed NCT02115945 - Femoral and Epidural Block After Total Knee Arthroplasty Phase 0
Completed NCT05096468 - Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms. Phase 2/Phase 3