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A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

NCT01544361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2014-07-23

Study results available
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Summary

This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

Conditions

  • Healthy Subjects

Interventions

OTHER

Placebo

A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.

BIOLOGICAL

MEDI7814, 1 MG/KG

A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.

BIOLOGICAL

MEDI7814, 3 MG/KG

A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.

BIOLOGICAL

MEDI7814, 10 MG/KG

A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.

BIOLOGICAL

MEDI7814, 20 MG/KG

A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Alan Marion, MD · Research site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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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 NCT01544361 on ClinicalTrials.gov