Meijisubsidiary Meiji Seika Pharma has commenced a Phase III clinical trial of a messenger ribonucleic acid (mRNA) vaccine, ARCT-154, for Covid-19 in Japan.
The observer-blind, multicentre, randomised, active-controlled, comparative trial is funded partially by the Ministry of Health, Labour and Welfare of Japan.
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It will analyse the immunogenicity and safety of ARCT-154 in healthy adult subjects aged 18 years and above.
The trial will enrol subjects who have previously received three doses of an approved mRNA Covid-19 vaccine, a minimum of three months ago.
It anticipates enrolling a total of 780 subjects, with 390 each in the ARCT-154 and Comirnaty arms.
In the trial, a 5µg intramuscular dose of ARCT-154 will be given to trial subjects.
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By GlobalDataThe trial, which started in November this year, will continue until April 2024.
Developed by Arcturus Therapeutics, ARCT-154 is claimed to be effective against SARS-CoV-2 viral variants, including the Omicron variant.
In addition, the vaccine could require a low vaccination dosage and have long-lasting effects.
Meiji also has plans to set up a domestic production system, using a subsidy from the Ministry of Economy, Trade and Industry.
In April this year, the company dosed the first subject in a Phase II clinical trial of a selective phosphodiesterase-4 (PDE4) inhibitor, ME3183, in plaque psoriasis patients in the US and Canada.
The double-blind, randomised, placebo-controlled trial was designed to assess the safety, efficacy, and tolerability of ME3183 for 16 weeks.
A total of 125 subjects were planned to be enrolled at nearly 30 US and Canadian sites for this trial.
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