drugset
drugset / Trial / NCT04169256

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

NCT04169256 ↗

Phase 1 Completed 32 enrolled Fruithy Medical Pty Ltd
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2020-03-03
Primary completion
2020-07-30
Completion
2020-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 200 mg Subcutaneous
Subject HYR-PB21 Unknown 100 mg Subcutaneous
Subject HYR-PB21 Unknown 200 mg Subcutaneous
Subject HYR-PB21 Unknown 400 mg Subcutaneous

Indications

No indication recorded.