New Delhi: Zydus Cadilla has started the Adaptive Phase I/ II human clinical trials of its plasmid DNA vaccine, ZyCoV-D 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 compay said in a statement.
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.
The plasmid DNA vaccine ZyCoV-D, designed and developed by Zydus and partially funded by the Department of Biotechnology is the second potential vaccine candidate after Bharat Biotech’s COVAXIN which got the approval for human clinical trial by the Central Drug Standard Control Organisation.