Gennova Gets DCGI Nod To Conduct Phase 2,3 Trials Of Its MRNA COVID-19 Vaccine

[email protected]13 Sep, 2021News

Gennova Biopharmaceuticals, the Pune-based biotechnology company which is developing India's first mRNA-based COVID-19 vaccine HGCO19, on August 24 received approval from the Drug Controller General of India (DCGI) to conduct Phase 2 and Phase 3 clinical trials. Gennova submitted the proposed Phase II and Phase III study titled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects', which was approved by the office of the DCGI.

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