Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766931
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2021-02-04
Brief Title:
The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection
Sponsor:
Frontier Biotechnologies Inc
Organization:
Frontier Biotechnologies Inc
Study Overview
Official Title:
A Two-part Phase III 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
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an adaptive Phase III 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None