NEW DELHI: Drug firm Zydus Cadila on Wednesday said the phase I clinical trial of its COVID-19 vaccine candidate, ZyCoV-D, has been completed and it will commence phase II clinical trials from August 6.
“ZyCoV-D was found to be safe and well tolerated in the phase I clinical trial. The company will now commence phase II clinical trials from the 6th of August, 2020.
“The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial, which began on July 15, 2020, has been well tolerated,” Cadila Healthcare, the listed entity of the group, said in a regulatory filing.
Zydus Cadila Chairman Pankaj R Patel said the phase I dosing to establish the safety of ZyCoV-D is an important milestone.
“All the subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and the vaccine was found to be very safe. We now begin the phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” he added.
Last month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender – the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
It got approval a few days after India’s first indigenous COVID-19 vaccine candidate COVAXIN, developed by city-based Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology, got the nod for human clinical trials from the Drug Controller General of India
(AGENCIES)
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