NCT02018250

Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety and Efficacy

Interventions

Type	Name	Description
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	Placebo	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.

Timeline

• Start date: 2012-03-17
• Primary completion: 2012-10-16
• Completion: 2012-12-01
• First posted: 2013-12-23
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States