Based on the human clinical experience with ARCT-021 we initiated the present accelerated, integrated phase 1/2/3a/3b study, designed following EMA, FDA and WHO guidance, to evaluate the safety, reactogenicity, immunogenicity, and efficacy of ARCT-154. We present the first study results up ...
Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), regarding the trial design. * References: https://covariants.org/per-country ...