Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04138043
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2019-10-22
Brief Title:
Safety Tolerability Pharmacokinetics Pharmacodynamics of GSK2330811 in Healthy Japanese Participants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase 1 Randomised Double-blind Placebo-controlled Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of GSK2330811 in Healthy Japanese Participants
Status:
COMPLETED
Status Verified Date:
2021-04
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 double-blind sponsor-open placebo-controlled single-center study involving Japanese participants The purpose of the study is to assess the safety tolerability pharmacokinetics PK pharmacodynamics PD and immunogenicity after a single subcutaneous SC dose of GSK2330811 in healthy Japanese participants GSK2330811 is a humanized immunoglobulin G1 IgG1 monoclonal antibody that binds and inhibits the action of Oncostatin M OSM and is being developed for the treatment of Crohns disease CD and Systemic sclerosis SSc Participants will be randomized to receive either GSK2330811 450 milligram mg or placebo in an approximate ratio of 73
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