drugset / Trial / NCT04766931

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

NCT04766931 ↗

Phase 1 Completed 88 enrolled Frontier Biotechnologies Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-03-17
Primary completion
2022-08-12
Completion
2022-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject FB2001 Small molecule — Intravenous

Indications