NCT01093040

A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects

A Phase I, Single-Center, Single-blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CAT-354 Following Subcutaneous Administration in Healthy Male and Female Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.

Detailed description

The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CAT-354	150 mg CAT-354 or placebo given SC on Day 1
DRUG	CAT-354	300 mg CAT-354 or placebo given SC on Day 1
DRUG	CAT 354	600 mg CAT-354 or placebo given SC on Day 1

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-05-01
• Completion: 2010-10-01
• First posted: 2010-03-25
• Last updated: 2012-08-30

Locations

1 site across 1 country: United States