Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants

Part I (SAD) - Healthy Participants Clinical Trial

Official title: Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI3506 Administered as Single Ascending Doses in Healthy Adult Subjects, as Multiple Ascending Doses in COPD Subjects and Single Dose in Healthy Japanese Subjects

Status Completed

Clinical Trial Summary

This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.

Clinical Trial Description

This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506 administered by either subcutaneous (SC) or intravenous (IV) routes.

Part I: Single Ascending Doses in Healthy Participants with a History of Mild Atopy

Part II: Multiple Ascending Doses in Participants with Global Initiative for Chronic Obstructive Lung Disease (GOLD) I-II Chronic Obstructive Pulmonary Disease (COPD)

Part III: Single Dose in Healthy Japanese Participants ;

Related Conditions & MeSH terms

• Lung Diseases, Obstructive
• Part I (SAD) - Healthy Participants
• Part II (MAD) - Chronic Obstructive Pulmonary Disease
• Part III (J-SD) - Healthy Japanese Participants
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT03096795
• Study type: Interventional
• Source: MedImmune LLC
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2017
• Completion date: September 30, 2019