Covid-19: Akston Biosciences doses first subjects in AKS-452 study
Beverly: Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, has announced that the first of 100 subjects were dosed in an open-label bridging study of AKS-452, its protein subunit COVID-19 vaccine candidate, in India.
AKS-452 is shelf stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).
India's Drug's Controller General of India (DCGI), Ministry of Health and Family Welfare, approved the open-label bridging study, being conducted by the Supe Heart & Diabetes Hospital and Research Centre, in Nashik, India along with four other sites in the state of Maharashtra. Veeda Clinical Research Ltd., a CRO with experience overseeing complex clinical trials, is managing the study.
The open-label bridging study will be conducted with 100 healthy volunteers, age 18 and older. The first participants were dosed under the supervision of principal investigator, Pravin Dinkar Supe, M.D. founder of the Supe Heart & Diabetes Hospital and Research Centre. A double-blind Phase II/III study will follow with 1,500 healthy volunteers, age 18 and older, across 12 clinical sites in five states across India.
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