NCT04590430

Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose First-in-Human Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered HFB30132A, a Monoclonal Antibody Directed Against SARS-CoV-2, in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HiFiBiO Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center.

Detailed description

This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and dose escalation study in healthy volunteers. The study will comprise of: 1. A Screening Period of up to 30 days (Day -30 through Day -1); 2. A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 24 hours after IMP administration, will be discharged on Day 2 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and 3. A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a single study center in Cincinnati.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HFB30132A	Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 and 3 will receive HFB30132A doses 2 and 3, respectively.
OTHER	Placebo	Participants randomized to placebo will receive the same volume of solution as participants on active treatment.

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-07-26
• Completion: 2021-07-26
• First posted: 2020-10-19
• Last updated: 2022-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study