Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects
- Registration Number
- NCT01357759
- Lead Sponsor
- Morphotek
- Brief Summary
This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo MORAb-022 Subjects with RA will be also randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo). Escalating doses of MORAb-022 MORAb-022 Subjects with RA will be randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).
- Primary Outcome Measures
Name Time Method Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA. Approximately 113 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Seaview Jacksonville, LLC
🇺🇸Jacksonville, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Pharmaceutical Research Associates Group B.V.
🇳🇱Zuidlaren, Netherlands