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

NCT01357759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-11-16

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Morphotek

    lead INDUSTRY

Principal Investigators

  • Alan J. Kivitz, MD, CPI · Altoona Center for Clinical Research

  • Lydie Hazan, MD · Axis Clinical Trials

  • Chrysoula Pappa, MD · Seaview Jacksonville, LLC

  • William M Schnitz, MD · Lynn Health Science Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT01357759 on ClinicalTrials.gov