This randomized, placebo-controlled, ascending dose study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers. A total of three cohorts will be dosed and evaluated at the Medpace Clinical Pharmacology Unit in Cincinnati, Ohio. All available safety, tolerability, and PK data for each cohort will be reviewed and evaluated by the Dose Escalation Committee. The second cohort will be dosed after the first cohort data is reviewed and the antibody is determined to be safe. To date, no adverse events have been observed.
“This Phase I study is a major milestone in HiFiBiO’s evolution from a pre-clinical organization to a clinical-stage company, and it takes us one step closer to addressing this critical pandemic situation around the world,” said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. “The fact that we have rapidly advanced this antibody from discovery to the dose of the first Phase I cohort in just eight months is a great testament to the capabilities of our cutting-edge technology, our talented team, and our strategic partners around the world. We believe HFB30132A is uniquely positioned to treat patients early during infection, especially high-risk adults, to reduce instances of COVID-19 hospitalization and complications.”
“We are excited about the opportunity to collaborate with the HiFiBiO team on this novel therapy,” said Leela Vrishabhendra, MD, Senior Medical Director of Medpace Clinical Pharmacology Unit. “HFB30132A has the potential to provide a critical layer of defense for COVID-19 positive individuals, especially those with underlying risk factors, such as cardiovascular disease or compromised immune system. This antibody can help fight off an active infection and prevent a cascade of severe complications that we have been witnessing globally.”
Later this year, the Phase II/III study is planned to enroll high-risk adults with asymptomatic or mild to moderate COVID-19 to assess efficacy after the primary data readout demonstrates that HFB30132A can be safely administered.
Source: Company Press Release