Reliance Life Sciences has sought regulatory approval to conduct early-stage human trials of its two-dose COVID-19 vaccine candidate, reports said on August 26.
The Subject Expert Committee (SEC) will review the application for Phase I trial of Reliance Life Sciences’ recombinant protein-based vaccine candidate on August 26, people familiar with the development told Economic Times.
The aim of phase I clinical trials is to obtain reliable information on safety, tolerability, pharmacokinetics (PK), and mechanism of action of drugs with the objective of determining the maximum tolerated dose (MTD), the report said.
Speaking about the duration of the trial, a source cited in the report, said, "Phase I trials are usually conducted for 58 days to check the tolerated dose strength. Once it's done, the company can approach for PhaseII/III trials."
Earlier this week, the Drugs Controller General of India (DCGI) granted approval for Phase 2 and 3 clinical trials of India's first mRNA Covid-19 vaccine candidate -- HGCO19 -- that is being developed by Gennova Biopharmaceuticals.
At present, India is administering three vaccines—Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V vaccine. Though US’ Moderna vaccine, Johnson and Johnson‘s single-dose vaccine and Zydus Cadila’s ZyCoV-D have received approval for emergency use, they are yet to be included in the nationwide inoculation drive.
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