Ignite Creation Date:
2024-05-06 @ 2:17 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02018250
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2012-12-27
Brief Title:
Study to Evaluate the Safety of a New Oxime MMB4 DIMETHANESULFONATE DMS
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase 1 Double-Blind Placebo-Controlled Single-Center Dose Escalation Study to Evaluate the Safety Tolerability and Pharmacokinetics of Intramuscular Administration of a New Oxime MMB4 DMS Enhanced Formulation EF
Status:
COMPLETED
Status Verified Date:
2024-05
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:
MMB4DMS
Brief Summary:
This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly im to the anterior thigh
Detailed Description:
The goal of this study is to assess safety tolerability and PK of MMB4 DMS EF at up to six cohorts chosen to provide the range required for PK analyses including assessment of dose proportionality
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S-12-08A-153992 | OTHER | USAMRMC | None |