NCT04169256

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fruithy Medical Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Postoperative Pain

Interventions

Type	Name	Description
DRUG	HYR-PB21	HYR-PB21 for injection 100mg, 200mg,or 400mg by single subcutaneous injection on the abdomen
DRUG	Liposomal bupivacaine	Liposome Bupivacaine Suspension for injection 200mg by single subcutaneous injection on the abdomen
OTHER	Normal Saline	Normal Saline 30ml, or 40mL by single subcutaneous injection on the abdomen

Timeline

• Start date: 2020-03-03
• Primary completion: 2020-07-30
• Completion: 2020-07-30
• First posted: 2019-11-19
• Last updated: 2021-02-04

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study