Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397911
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-30
Brief Title:
Evaluate Efficacy Pharmacokinetics and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Oneness Biotech Co Ltd
Organization:
Oneness Biotech Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy Pharmacokinetics and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-09
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 a randomized placebo-controlled and double-blind study to evaluate the efficacy pharmacokinetics and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis
Detailed Description:
This multicenter randomized double-blind placebo-controlled 2-arm parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis with approximately 45 subjects per group
The study duration of subject participation in the study is up to 28 weeks including up to 4 weeks for screening a 12-week study intervention and a 12-week follow-up period after study intervention The study treatment will be administered as 5 SC doses
The study duration of subject participation in the study is up to 28 weeks including up to 4 weeks for screening a 12-week study intervention and a 12-week follow-up period after study intervention The study treatment will be administered as 5 SC doses
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