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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771420 on ClinicalTrials.gov