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A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma

NCT00783289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-12-27

Study results available
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Summary

The primary objective of this study is to evaluate the safety and tolerability of escalating multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.

Conditions

Interventions

OTHER

Placebo

Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.

BIOLOGICAL

Benralizumab 25 mg

Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.

BIOLOGICAL

Benralizumab 100 mg

Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.

BIOLOGICAL

Benralizumab 200 mg

Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • David Gossage, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-14
Primary Completion
2009-11-17
Completion
2009-11-17

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 NCT00783289 on ClinicalTrials.gov