NCT01544361

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-03-05
• Last updated: 2014-07-23
• Results posted: 2014-07-23

Locations

1 site across 1 country: United States