Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03846466
Status:
TERMINATED
Last Update Posted:
2020-01-28
First Post:
2019-02-17
Brief Title:
Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis
Sponsor:
Kyowa Kirin Co Ltd
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers and Subjects With Atopic Dermatitis
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study terminated for safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part 1 To investigate the safety and tolerability of intravenous IV or subcutaneous SC administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind placebo-controlled study
Part 2 To investigate the safety and tolerability of intravenous IV administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind placebo-controlled study
Part 2 To investigate the safety and tolerability of intravenous IV administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind placebo-controlled study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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