Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-25 @ 10:53 PM
Study NCT ID:
NCT02018250
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2012-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
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:
MMB4(DMS)
Brief Summary:
This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) 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:
True
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 |
|---|---|---|---|---|
| S-12-08/A-15399.2 | OTHER | USAMRMC | View |