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Clinical Development

Medpace Clinical Pharmacology Unit working with HiFiBIO Therapeutics on a SARS-CoV-2 ID-neutralizing antibody for the treatment and prevention of COV19

  • October 29, 2020
In a recent news release, HiFiBiO Therapeutics announced the successful completion of the first cohort of the Phase I study (NCT04590430) of HFB30132 which was conducted in Medpace’s Clinical Pharmacology Unit in Cincinnati, OH.

This randomized, placebo-controlled, ascending dose study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers.

“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.”

A total of three cohorts will be dosed and evaluated at the Medpace facility. 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.

Read the full news release here.