Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01614756
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2015-08
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 determine safety and tolerability of IL-31 mAB
Detailed Description:
Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001865-34 | EUDRACT_NUMBER | None | View |