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news.India-based pharmaceutical firm Zydus Cadila has completed the single ascending dose (SAD) range finding Phase I trial of ZYAN1 being conducted in Australia in healthy human volunteers.
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ZYAN1 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor being developed to increase the natural production of erythropoietin (EPO) as well as the efficacy of injectable EPO stimulating agents in anemic patients.
The Phase I trial was designed to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZYAN1 in healthy volunteers.
During the dose ranging trial, ZYAN1 was administered up to 150mg orally, once-a-day to healthy human volunteers as part of single ascending dose finding trials.
As part of this trial, pharmacokinetics, erythropoietin and other biomarker responses were also measured in the healthy volunteers.
Zydus Cadila chairman and managing director Pankaj Patel said: "This is an important innovation that will radically change the treatment paradigm in anemia.
"ZYAN1 has the potential to become an oral therapy for treating patients with anemia with significant advantages over currently available injectable EPO stimulating agents (ESAs)."
The multiple ascending doses of ZYAN1 in healthy human volunteers have been initiated and is expected to be completed by the second quarter of 2015.
Additionally, the effect of food and gender on the pharmacokinetics of ZYAN1 will also be studied.
Image: ZYAN1 is being developed to increase the natural production of erythropoietin in anemic patients. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.