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A Sequential Dose-Escalation Study in Subjects With Mild Asthma

NCT00512486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2008-11-27

No results posted yet for this study

Summary

The primary objective of this study is to investigate the safety of administration of this drug by increasing doses to male and female adult subjects with mild asthma.

Conditions

Interventions

BIOLOGICAL

MEDI-563

BIW-8405/MEDI-563 administered at one of five dose levels: * 0.03 mg/kg intravenous injection * 0.1 mg/kg intravenous injection * 0.3 mg/kg intravenous injection * 1.0 mg/kg intravenous injection * 3.0 mg/kg intravenous injection Following the -3.0 mg/kg dose level, BIW-8405/MEDI-563 administered at one of two lower dose levels: 0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Nestor Molfino, M.D. · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-09-30
Completion
2008-10-31

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 NCT00512486 on ClinicalTrials.gov