Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05277571
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-03-03
Brief Title:
A Single-ascending Dose Part A and Repeat-dose Part B Study to Investigate the Safety Pharmacokinetics and Efficacy Part B Only of UCB1381 in Healthy Study Participants Part A and in Study Participants With Moderate to Severe Atopic Dermatitis Part B
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Phase 12A Randomized Placebo-Controlled Single-Ascending Dose Part A Participant- and Investigator-Blind and Repeat-Dose Part B Participant- Investigator- and Sponsor-Blind Study to Investigate the Safety Pharmacokinetics and Efficacy Part B Only of UCB1381 in Healthy Study Participants Part A and in Study Participants With Moderate to Severe Atopic Dermatitis Part B
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 intravenous and subcutaneous in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None