Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386436
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2015-03-06
Brief Title:
A Safety Tolerability Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase I Randomised Double-blind Sponsor Open Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-05
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:
GSK2330811 is a humanised monoclonal antibody that blocks Oncostatin M OSM which is being developed for the treatment of inflammatory and fibrotic diseases This first time in human study will evaluate the safety tolerability pharmacokinetic PK pharmacodynamic PD and immunogenicity profile of single ascending subcutaneous sc doses of GSK2330811 in healthy subjects
This study will be a randomised double-blind sponsor open placebo-controlled single centre single dose escalation study of sc administrations of GSK2330811 in healthy subjects Approximately 40 subjects will be enrolled in the study across 5 cohorts Each cohort is planned to consist of 8 subjects randomised such that 6 subjects will receive GSK2330811 and 2 subjects will receive placebo
The starting dose for the study will be 01 milligram mgkilogram kg sc single dose and the highest dose will be 6 mgkg sc single dose Subjects will be admitted to the clinical unit on the day prior to dosing Day -1 On Day 1 each subject will receive a sc dose of GSK2330811 or placebo Subjects will then remain as an in-patient until discharged on Day 8 after assessments have been performed The duration of the study including screening is approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5
This study will be a randomised double-blind sponsor open placebo-controlled single centre single dose escalation study of sc administrations of GSK2330811 in healthy subjects Approximately 40 subjects will be enrolled in the study across 5 cohorts Each cohort is planned to consist of 8 subjects randomised such that 6 subjects will receive GSK2330811 and 2 subjects will receive placebo
The starting dose for the study will be 01 milligram mgkilogram kg sc single dose and the highest dose will be 6 mgkg sc single dose Subjects will be admitted to the clinical unit on the day prior to dosing Day -1 On Day 1 each subject will receive a sc dose of GSK2330811 or placebo Subjects will then remain as an in-patient until discharged on Day 8 after assessments have been performed The duration of the study including screening is approximately 19 weeks for Cohorts 1 to 4 and 23 weeks for Cohort 5
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