CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 125 enrolled
Drug / intervention
MEDI7814, 1 MG/KG +4 morebiological
Likely dose
MEDI7814, 1 MG/KGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01544361
NCT01544361Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

MedImmune LLC·interventional·Posted Mar 5, 2012·Updated Jul 23, 2014

In Brief

A Phase 1 clinical trial evaluating Placebo, MEDI7814, 1 MG/KG, and 3 other interventions for Healthy Subjects. Completed, enrolled 125 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2012
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.3 years ago

Interventions

Placeboother

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

MEDI7814, 1 MG/KGbiological

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

MEDI7814, 3 MG/KGbiological

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

MEDI7814, 10 MG/KGbiological

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

MEDI7814, 20 MG/KGbiological

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