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

NCT04766931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-11-28

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • Frontier Biotechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Cheng Yao · Frontier Biotechnologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2022-08-12
Completion
2022-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766931 on ClinicalTrials.gov