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Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-110 in Subjects With Rheumatoid Arthritis

NCT01878123 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-09-30

No results posted yet for this study

Summary

This is a Phase 1, single-dose, placebo-controlled, dose-escalation,multi-center, first time in human study of AMP-110 in adult subjects with rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

AMP-110

Dose levels 1 through 7: Single intravenous infusion on Day 0

OTHER

Placebo

Dose levels 4 through 7: Single intravenous infusion on Day 0

Sponsors & Collaborators

  • Daiichi Sankyo Co., Ltd.

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

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 NCT01878123 on ClinicalTrials.gov