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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

September 2, 2010
November 22, 2012
June 2010
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01195207 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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
  • Experimental: 001
    CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 002
    CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 003
    CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 004
    CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 005
    CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 006
    CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 007
    CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
  • Experimental: 008
    CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion
    Intervention: Biological: CNTO 3157 or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
January 2012
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   United Kingdom
 
NCT01195207
CR017095
Not Provided
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP