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Business EconomyPosted at: Jul 15 2020 1:25PM


Zydus starts Human Dosing for Adaptive Phase I & II clinical trials

Mumbai, Jul 15(UNI)Pharma major Zydus, on Wednesday said that the Adaptive Phase I / II human clinical trials of its plasmid DNA vaccine, ZyCoV-D commenced today with the first human dosing.
The Adaptive Phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine. The human dosing of the vaccine marks a key milestone since the launching of the accelerated vaccine development programme for COVID-19 in February 2020.
Commenting on the development, Chairman, Zydus Cadila, Mr. Pankaj R. Patel said, "This is an all important step in our fight against COVID-19. We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt. of India and regulatory agencies ICMR and DGCI in the development of ZyCoV-D vaccine candidate. We look forward to the Adaptive Phase I/IIclinical studies and gathering important data on ZyCoV-D in the months ahead."
In the Adaptive Phase I / II clinical trials, Zydus will be enrolling over 1000 subjects across multiple clinical study sites in India. The company has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials.
Zydus had earlier this month announced that its plasmid DNA vaccine candidate (ZyCoV-D) developed at its Vaccine Technology Centre in Ahmedabad, India, has successfully completed the preclinical phase and had received permission from the Drug Controller General of India (DGCI) - Central Drugs Standard Control Organization (CDSCO) to initiate Adaptive Phase I / II human clinical trials in India.
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