Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)
NCT02018250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-05-23
Summary
This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) to the anterior thigh.
Conditions
- Safety and Efficacy
Interventions
- DRUG
-
MMB4 DMS
Subjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe.
- DRUG
-
Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort.
Sponsors & Collaborators
-
U.S. Army Medical Research and Development Command
lead FED
Principal Investigators
-
Mohamed S Al-Ibrahim, MD · SNBL Clinical Pharmacology Center, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-03-17
- Primary Completion
- 2012-10-16
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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