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Virus Therapy

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

Phase 1
Waitlist Available
Research Sponsored by Frontier Biotechnologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0~28 days

Summary

This trial tests a new drug, FB2001, on healthy people to ensure it's safe and on COVID-19 patients to see if it helps them recover. The goal is to find a safe dose and check its effectiveness against COVID-19.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0~28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
Pharmacokinetic parameters(AUC0-τ)
Pharmacokinetic parameters(Cmax)
+1 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: B3 FB2001 or PlaceboExperimental Treatment2 Interventions
Twice daily for 5 days
Group II: B2 FB2001 or PlaceboExperimental Treatment2 Interventions
Once daily for 5 days
Group III: B1 FB2001 or PlaceboExperimental Treatment2 Interventions
Once daily for 5 days
Group IV: A8 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group V: A7 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group VI: A6 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group VII: A5 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group VIII: A4 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group IX: A3 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group X: A2 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Group XI: A1 FB2001 or PlaceboExperimental Treatment2 Interventions
single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FB2001
2021
Completed Phase 1
~130
FB2001 Placebo
2021
Completed Phase 1
~90

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Frontier Biotechnologies Inc.Lead Sponsor
13 Previous Clinical Trials
3,448 Total Patients Enrolled
Cheng YaoStudy DirectorFrontier Biotechnologies Inc.
4 Previous Clinical Trials
2,588 Total Patients Enrolled
~19 spots leftby Dec 2025
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