A Study to Assess Pharmacokinetics, Safety and Tolerability of Multiple Doses of CAT-354 in Subjects With Moderate Asthma

Phase 1 Terminated 23 enrolled MedImmune LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.

Timeline

Start: 2006-09-29
Primary completion: 2007-08-03
Completion: 2007-08-03

Outcome

Outcome not reported

Stopped (Enrollment): “Study recruitment was terminated before the planned number of subjects was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.”

Publications

Background Singh D, Kane B, Molfino NA, Faggioni R, Roskos L, Woodcock A. A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. BMC Pulm Med. 2010 Jan 8;10:3. doi: 10.1186/1471-2466-10-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tralokinumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Tralokinumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Tralokinumab	Monoclonal antibody	10 mg/kg	Intravenous

Indications

No indication recorded.