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

Healthy Clinical Trial

Official title:
A Phase I Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety, Tolerability, and Pharmacokinetics of Single Dose Intravenously Administered HFB30132A, a Monoclonal Antibody Against SARS-CoV-2, in Chinese Healthy Adult Subjects

Clinical Trial Summary

The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.

Clinical Trial Description

This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese 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 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and 3. A Follow up Period lasting 270 days after the IMP dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05275660
Study type Interventional
Source HiFiBiO Therapeutics
Contact
Status Completed
Phase Phase 1
Start date May 9, 2021
Completion date February 22, 2022
View Details
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