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

Centocor Ortho Biotech

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Biological: CNTO 3157 or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01195207

CR017095

Details and patient eligibility

About

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

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

79 participants in 8 patient groups

001

Experimental group

Description:

CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

002

Experimental group

Description:

CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

003

Experimental group

Description:

CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

004

Experimental group

Description:

CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

005

Experimental group

Description:

CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

006

Experimental group

Description:

CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

007

Experimental group

Description:

CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

008

Experimental group

Description:

CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion

Treatment:

Biological: CNTO 3157 or placebo

Trial contacts and locations

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trials Trials by location

Research sites

Find research sites Learn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy Notice Terms