Dexpramipexole SAD/MAD Study
NCT01449578 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2014-11-25
Summary
This Phase 1 study will explore the safety, tolerability, and pharmacokinetics of single doses ranging from 300 to 600 mg and multiple daily doses ranging from 225 mg to 300 mg BID dexpramipexole in healthy volunteers.
Conditions
Interventions
- DRUG
-
Dexpramipexole
Oral Tablet at varying doses
- DRUG
-
Dexpramipexole Placebo
Oral tablet at varying doses
Sponsors & Collaborators
-
Knopp Biosciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2012-01-31
- Completion
- 2012-01-31
Countries
- United States
Study Locations
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