NCT04766931

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	FB2001	Subjects will be administered with FB2001 by intravenous (IV) infusion
DRUG	FB2001 Placebo	Subjects will be administered with FB2001 placebo by intravenous (IV) infusion

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-02-23
• Last updated: 2022-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study