NCT02669667

Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects

A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

Detailed description

This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Conditions

• Safety
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	MEDI9314	single dose of MEDI9314
DRUG	placebo	single dose of placebo

Timeline

• Start date: 2016-02-18
• Primary completion: 2016-11-17
• Completion: 2017-06-12
• First posted: 2016-02-01
• Last updated: 2019-06-04
• Results posted: 2019-05-15

Locations

2 sites across 2 countries: United States, United Kingdom