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

ClinicalTrials.gov ID: NCT04766931

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04766931
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Frontier Biotechnologies Inc.; Industry
Enrollment: 88 participants

Conditions and interventions

Conditions

Covid19

Interventions

FB2001 Drug
FB2001 Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 60 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 17, 2021 (Actual)
Primary completion: Aug 12, 2022 (Actual)
Completion: Aug 12, 2022 (Actual)
Last update posted: Nov 28, 2022

2021 – 2022

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Frontage Clinical Services, Inc.	Secaucus	New Jersey	07094	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04766931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 28, 2022 · Synced Nov 14, 2026