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

NCT04169256 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-02-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fruithy Medical Pty Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2020-07-30
Completion
2020-07-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169256 on ClinicalTrials.gov