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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01195207
First received: September 2, 2010
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Asthma
Biological: CNTO 3157 or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of CNTO 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events [ Time Frame: Week 21 for Part 1 and Week 24 for Part 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effects of CNTO3157 on the body and the effects of the body on CNTO 3157 (Pharmacokinetics (PK), Pharmacodynamics (PD)) [ Time Frame: Week 21 for Part 1 and Week 24 for Part 2 ] [ Designated as safety issue: No ]
  • Immune response (Immunogenicity) [ Time Frame: Week 21 for Part 1 and Week 24 for Part 2 ] [ Designated as safety issue: No ]
  • Clinical Response [ Time Frame: Week 21 for Part 1 and Week 24 for Part 2 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: June 2010
Study Completion Date: January 2012
Arms Assigned Interventions
Experimental: 001
CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Experimental: 002
CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Experimental: 003
CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Experimental: 004
CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 005
CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Experimental: 006
CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Experimental: 007
CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Experimental: 008
CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
  • Patients with asthma must have been diagnosed at least 6 months prior to participation in the study

Exclusion Criteria:

  • Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • Have a positive pregnancy test at screening or prior to dose administration
  • Have smoked tobacco or related products within 6 months prior to dosing
  • Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
  • Recent history (within previous 6 months) of alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195207

Locations
Belgium
Antwerp, Belgium
Merksem, Belgium
Germany
Berlin, Germany
United Kingdom
Harrow, United Kingdom
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01195207     History of Changes
Other Study ID Numbers: CR017095
Study First Received: September 2, 2010
Last Updated: November 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
CNTO 3157
healthy volunteers
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014