NCT01357759

Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MORAb-022	IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)
DRUG	MORAb-022	IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-05-23
• Last updated: 2015-11-16

Locations

5 sites across 2 countries: United States, Netherlands