Arcturus Therapeutics (ARCT) said late Monday the US Food and Drug Administration has given the clearance to begin the clinical study for its H5N1 pandemic flu vaccine candidate ARCT-2304.
The company said the trial, which is funded by the Biomedical Advanced Research and Development Authority, is designed to enroll around 200 healthy adults in the US.
The phase 1 trial aims to evaluate the safety, reactogenicity, and immunogenicity of the "self-amplifying" mRNA vaccine, Arctus said.
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