Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-11 @ 11:25 AM
Study NCT ID:
NCT02235727
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects
Sponsor:
Glenmark Pharmaceuticals Ltd. India
Organization:
Study Overview
Official Title:
A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-01
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:
A Single Dose Study of GBR 900 in Healthy Volunteers.
Detailed Description:
This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-005480-31 | EUDRACT_NUMBER | None | View |