Assess the tolerability of a novel test item administered by the subcutaneous route to Sprague Dawley rats
Challenge

Professor Ranjeny Thomas is the founder of a University of Queensland spin-out company called Dendright Pty Ltd. Dendright is developing a novel therapeutic product for the treatment of rheumatoid arthritis. Regulatory agencies such as the US Food and Drug Administration (FDA) and the Therapeutic Goods Administration (TGA) in Australia require that new therapeutic products are suitably safe and well-tolerated before progressing to safety and tolerability testing in healthy human subjects. Hence this study was designed to provide information on the safety and tolerability of a single parenterally-administered dose of test or control item in Sprague-Dawley rats followed by a 2-week observation period. This study design was specifically chosen to support the overall design of the GLP safety program.

How did the facility help?

To address this challenge, CIPDD personnel undertook the afore-mentioned acute dose toxicity study of the novel therapeutic product being developed by Dendright Pty Ltd. The data thus generated will be included in documents for submission to regulatory agencies.

Outcome

The study results are crucial in demonstrating the safety and tolerability in rats of a single parenterally-administered dose of the test item being developed by Dendright Pty Ltd.

 “CIPDD provided excellent project management and technical support at all stages of the single dose study. The team responded in a timely fashion to all queries we had from study conception through data review through final report. CIPDD conducted the study with a high level of diligence and oversight and the final report adequately reflected comments and input from the Dendright drug development team. We were very happy with the outcome from a quality perspective.” – Dendright Pty Ltd

Background

The CIPDD at The University of Queensland has state-of-the-art physical infrastructure and it is a NATA GLP-recognized new drug development facility. Core capabilities include (i) Preclinical efficacy profiling of new molecules from novel analgesics discovery programs and mode of action assessment, (ii) conduct of the in-life phases of rodent pharmacokinetic and GLP toxicology studies, as well as (iii) bioanalysis in support of collaborative research projects in collaboration with clinicians and university-based researchers.

Centre for Integrated Preclinical Drug Development 

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Melbourne 3000 VIC

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