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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO3175NAP1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men. Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion. The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center). During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo. Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157. Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level. The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner. An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B). Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo. Only Caucasian participants will be enrolled in the IV treatment group (group 4). For each treatment group, blood and urine samples will be taken at various time points during the study. Each participant will take part in the study for approximately 85 days. Participant safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | 100 mg CNTO 3157 or placebo in healthy male Japanese participants |
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| Group 1B | Experimental | 100 mg CNTO 3157 or placebo in healthy male Caucasian participants |
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| Group 2A | Experimental | 300 mg CNTO 3157 or placebo in healthy male Japanese participants |
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| Group 2B | Experimental | 300 mg CNTO 3157 or placebo in healthy male Caucasian participants |
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| Group 3A | Experimental | 600 mg CNTO 3157 or placebo in healthy male Japanese participants |
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| Group 3B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg CNTO 3157 | Biological | A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157 |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157. | Up to Day 57 |
| Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg | Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug). | Up to Day 57 |
| Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg | Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response. | Up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg | Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug). | Up to Day 57 |
| Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
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600 mg CNTO 3157 or placebo in healthy male Caucasian participants |
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| Group 4 | Experimental | 300 mg CNTO 3157 in healthy male Caucasian participants |
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| 300 mg CNTO 3157 | Biological | 2 SC injections of CNTO 3157 providing a total dose of 300 mg |
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| 600 mg CNTO 3157 | Biological | 4 SC injections of CNTO 3157 providing a total dose of 600 mg |
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| 300 mg CNTO 3157 | Biological | 300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes |
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| Placebo | Drug | SC injections of placebo (number of injections to equal number of injections of CNTO 3157) |
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Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response. |
| Up to Day 57 |