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The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection

Covid19 Clinical Trial

Official title:
A Two-part, Phase I/II, Multi-center, Double-Blind, Randomized, Vehicle-controlled Study of the Safety and Efficacy of FB2001 in Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19) Infection

Clinical Trial Summary

This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to severe COVID-19 disease.

Clinical Trial Description

In Part 1 of this study, all subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. Only those subjects who successfully complete the screening phase and meet the study eligibility criteria will proceed to receive study treatment at the assigned doses and will be followed up for 14 days (for SAD) and 28 days (for MAD) to assess post-treatment safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04766931
Study type Interventional
Source Frontier Biotechnologies Inc.
Contact
Status Completed
Phase Phase 1
Start date March 17, 2021
Completion date August 12, 2022
View Details
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