A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis
NCT00771420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2012-07-20
Summary
Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.
Conditions
Interventions
- DRUG
-
CAM-3001
A single patient shall be dosed with a dose of 0.01mg/kg of CAM-3001 followed no sooner than 24 hours later by a second patient at a dose of 0.03mg/kg.
- DRUG
-
CAM-3001
Dosed at 0.1mg/kg.
- DRUG
-
CAM-3001
Dosed at 0.3mg/kg
- DRUG
-
CAM-3001
Dosed at 1.0 mg/kg.
- DRUG
-
CAM-3001
Dosed at 3.0 mg/kg.
- DRUG
-
CAM-3001
Dosed at 10 mg/kg.
- OTHER
-
Placebo
Active: Placebo 5:1 for arms 2-6
Sponsors & Collaborators
-
MedImmune Ltd
lead INDUSTRY
Principal Investigators
-
Ehsanollah Esfandiari, PhD MD · MedImmune LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2008-12-31
- Completion
- 2009-02-28
Countries
- Germany
Study Locations
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