Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNTO 3157 · 1 trial · 1 indication
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 |
| 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) |
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 being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The completed trial evaluated its safety and pharmacokinetics in healthy Japanese and Caucasian participants.
CNTO 3157 is a monoclonal antibody, but its specific molecular target has not been disclosed. The available information does not specify the target or mechanism of action. It is being studied for safety and pharmacokinetics in healthy participants.
CNTO 3157 is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is in Phase 1 clinical development and is not yet approved.
CNTO 3157 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
CNTO 3157 has one completed clinical trial, NCT02008279, titled "A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants." The study enrolled 40 male participants in the United States and was completed.