Zydus Cadila has commenced the adaptive phase I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D with the first human dosing. The safety, tolerability and immunogenicity of the vaccine will be assessed later on.
Earlier this month, the company had announced that its plasmid DNA vaccine candidate (ZyCoV-D) developed at its Vaccine Technology Centre (VTC) in Ahmedabad, had successfully completed the preclinical phase and also, received permission from Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate adaptive phase I/II clinical trials in India.
In the adaptive phase I/II clinical trials, Zydus will enroll over 1,000 subjects across its multiple clinical study sites in India. It has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials.
Last week, Zydus had received approval from the regulatory authority of Mexico, COFEPRIS, for its one of its lead research candidate-Desidustat to be tested in the management of COVID-19. As a part of the study, 100 mg tablets of Desidustat will be administered for a period of 14 days along with, recommended standard care, during the trial.
Zydus Cadila is putting all efforts to combat with the COVID-19 pandemic. Vaccine Technology Centre of Zydus Cadila is capable of developing and manufacturing viral, toxoid, polysaccharide, conjugate and others. Zydus was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010.
On Wednesday, the stock of Cadila Healthcare opened 1.7 per cent higher at Rs 359.70 from its previous close of Rs 353.65 on BSE.