NCT01596712

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	QGE031	QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
DRUG	Placebo	Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-05-11
• Last updated: 2012-11-22

Locations

1 site across 1 country: Japan