Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515834
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Investigating the Safety Tolerability Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Placebo-controlled Within-group Randomised and Double-blind Trial Investigating Safety Tolerability and Pharmacokinetics of FE 999301 After Single Ascending Doses in Healthy Japanese Men
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interleukin IL-6 is a cytokine produced in response to infection and tissue damage IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases IL-6 is known to be involved in at least two distinct signalling pathways classical and trans-signalling The hypothesis is that classical signalling by IL-6 infers some beneficial effects eg on gut barrier function while excessive IL-6 trans-signalling may have detrimental effects Olamkicept FE 999301 has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses it has proven to induce clinical improvement for patients with ulcerative colitis The aim of this trial is to investigate safety tolerability immunogenicity and pharmacokinetics of Olamkicept at higher doses to support the clinical development program The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None