NCT01195207

A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Intravenous Study in Healthy Subjects and a Multiple-Dose Intravenous Study in Asthmatic Subjects to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of CNTO 3157

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.

Detailed description

A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 3157, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic patients will take part. Volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157 will be administered by IV infusion. The duration of volunteer participation will be up to 21 weeks in Part 1 and up to 24 weeks in Part 2.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	CNTO 3157 or placebo	0.003 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	0.03 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	10 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	0.01 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	1 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	3 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	0.3 mg/kg CNTO 3157 or placebo infusion
BIOLOGICAL	CNTO 3157 or placebo	0.1 mg/kg CNTO 3157 or placebo infusion

Timeline

• Start date: 2010-06-01
• Completion: 2012-01-01
• First posted: 2010-09-06
• Last updated: 2012-11-27

Locations

4 sites across 3 countries: Belgium, Germany, United Kingdom