Zydus commences human clinical trials for ZyCoV-D

Zydus announced 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.

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 had successfully completed the preclinical phase and had received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Adaptive Phase I/II human clinical trials in India.

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