October 26, 2020 -- HiFiBiO Therapeutics has completed the first cohort of a phase I clinical study evaluating a SARS-CoV-2 neutralizing antibody.
The randomized, placebo-controlled study is assessing the safety of antibody HFB30132A, a potential therapeutic for the treatment and prevention of COVID-19. The trial will test the dose-ascending formulations of the antibody in 24 healthy volunteers at the Medpace Clinical Pharmacology Unit in Cincinnati, Ohio.
So far, one cohort has been dosed, and no adverse events have been observed. HiFiBiO will evaluate the safety, tolerability, and pharmacokinetics of the candidate in the first cohort before providing the next cohort with an ascending antibody dose.
The phase I study is the first step toward a planned phase II/III trial of HFB30132A later this year. HiFiBiO plans to enroll high-risk adults with COVID-19 who are asymptomatic, mildly symptomatic, or moderately symptomatic.
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