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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion |
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| 002 | Experimental | CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion |
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| 003 | Experimental | CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion |
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| 004 | Experimental | CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion |
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| 005 | Experimental | CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion |
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| 006 | Experimental | CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 3157 or placebo | Biological | 0.003 mg/kg CNTO 3157 or placebo infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of CNTO 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events | Week 21 for Part 1 and Week 24 for Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effects of CNTO3157 on the body and the effects of the body on CNTO 3157 (Pharmacokinetics (PK), Pharmacodynamics (PD)) | Week 21 for Part 1 and Week 24 for Part 2 | |
| Immune response (Immunogenicity) | Week 21 for Part 1 and Week 24 for Part 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | Belgium | |||||
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| 007 | Experimental | CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion |
|
| 008 | Experimental | CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion |
|
| CNTO 3157 or placebo |
| Biological |
0.03 mg/kg CNTO 3157 or placebo infusion |
|
| CNTO 3157 or placebo | Biological | 10 mg/kg CNTO 3157 or placebo infusion |
|
| CNTO 3157 or placebo | Biological | 0.01 mg/kg CNTO 3157 or placebo infusion |
|
| CNTO 3157 or placebo | Biological | 1 mg/kg CNTO 3157 or placebo infusion |
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| CNTO 3157 or placebo | Biological | 3 mg/kg CNTO 3157 or placebo infusion |
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| CNTO 3157 or placebo | Biological | 0.3 mg/kg CNTO 3157 or placebo infusion |
|
| CNTO 3157 or placebo | Biological | 0.1 mg/kg CNTO 3157 or placebo infusion |
|
| Clinical Response | Week 21 for Part 1 and Week 24 for Part 2 |
| Merksem |
| Belgium |
| Berlin | Germany |
| Harrow | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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