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Also known as CNTO 3157 (healthy participants)
CNTO 3157 · 2 trials · 2 indications
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
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.
| Arm | Type | Description |
|---|---|---|
| Group 1A | EXPERIMENTAL | 100 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 1B | EXPERIMENTAL | 100 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 2A | EXPERIMENTAL | 300 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 2B | EXPERIMENTAL | 300 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 3A | EXPERIMENTAL | 600 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 3B | EXPERIMENTAL | 600 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 4 | EXPERIMENTAL | 300 mg CNTO 3157 in healthy male Caucasian participants |
| Part 1: Healthy participants (CNTO 3157 + HRV-16) | EXPERIMENTAL | - |
| Part 1: Healthy participants (placebo + HRV-16) | PLACEBO_COMPARATOR | - |
| Part 2: Asthmatic patients (CNTO 3157 + HRV-16) | EXPERIMENTAL | - |
| Part 2: Asthmatic patients (placebo + HRV-16) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 100 mg CNTO 3157 | BIOLOGICAL | A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157 |
| 300 mg CNTO 3157 | BIOLOGICAL | 2 SC injections of CNTO 3157 providing a total dose of 300 mg |
| 600 mg CNTO 3157 | BIOLOGICAL | 4 SC injections of CNTO 3157 providing a total dose of 600 mg |
| Placebo | DRUG | SC injections of placebo (number of injections to equal number of injections of CNTO 3157) |
| CNTO 3157 (healthy participants) | DRUG | CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16). |
| Placebo (healthy participants) | DRUG | Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16. |
| CNTO 3157 (asthmatic patients) | DRUG | CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. |
| Placebo (asthmatic patients) | DRUG | Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16. |
| HRV-16 | OTHER | Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris. |
Inclusion Criteria: * Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive * Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as det...
CNTO 3157 is an investigational monoclonal antibody developed by Johnson & Johnson. It has been studied in Phase 1 clinical trials involving healthy volunteers, including a study in healthy Japanese and Caucasian participants and a study in healthy and asthmatic participants inoculated with human rhinovirus type 16.
CNTO 3157 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored both Phase 1 trials of the antibody, one conducted in the United States and one across Belgium, Canada, Denmark, Germany, the Netherlands, and the United Kingdom.
CNTO 3157 is in Phase 1 development. Both of its clinical trials, NCT02008279 and NCT01704040, are Phase 1 studies and both are completed, with no active trials currently listed. The drug remains investigational and has not been approved by the FDA.
CNTO 3157 has been evaluated in two completed Phase 1 trials. NCT02008279 studied safety and pharmacokinetics in 40 healthy Japanese and Caucasian male participants in the United States. NCT01704040 studied 76 healthy and asthmatic participants inoculated with human rhinovirus type 16 across six European countries and Canada.
CNTO 3157 trials were randomized, double-blind, and controlled, enrolling a total of 116 participants across the two completed Phase 1 studies. Participants were at least 18 years old, and the studies included healthy volunteers as well as asthmatic participants, with no biomarker-based selection.