Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT03385369
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2017-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
Sponsor:
MedImmune LLC
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Blinded, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
Status:
COMPLETED
Status Verified Date:
2019-04
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 phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of MEDI0382 following single dose administration to overweight/obese subjects of Japanese or Chinese descent
Detailed Description:
This is a phase I, randomized, blinded study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of MEDI0382 following single dose administration to overweight/obese but otherwise healthy adult male and female subjects of Japanese or Chinese descent
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: