Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
NCT00712114 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2011-06-14
Summary
The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential anti-inflammatory activity of an investigational agent, HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are taking a stable dose of methotrexate.
Conditions
Interventions
- DRUG
-
HE3286
HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.
- DRUG
-
HE3286
HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days
- DRUG
-
HE3286
HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days
Sponsors & Collaborators
-
Harbor Therapeutics
lead INDUSTRY
Principal Investigators
-
Dwight Stickney, MD · Hollis-Eden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2009-07-31
- Completion
- 2009-07-31
Countries
- United States
Study Locations
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