NCT01205087

Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody in Patients With the Metabolic Syndrome PHASE IIa A Single-blinded Placebo-controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

Detailed description

PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	OKT3	Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2011-04-01
• First posted: 2010-09-20
• Last updated: 2011-06-23

Locations

1 site across 1 country: Israel