Recent Updates
Recently added Catalysts

CNTO 3157

Phase 1

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: Sep 30, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02008279A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian ParticipantsPHASE1 COMPLETED 40 — — Dec 1, 2013Aug 1, 2014Sep 30, 20141 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Frequency of adverse events
Up to Day 57

The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.

Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Up to Day 57

Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).

Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Up to Day 57

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.

Secondary Endpoints
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Up to Day 57
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Up to Day 57
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1AEXPERIMENTAL100 mg CNTO 3157 or placebo in healthy male Japanese participants
Group 1BEXPERIMENTAL100 mg CNTO 3157 or placebo in healthy male Caucasian participants
Group 2AEXPERIMENTAL300 mg CNTO 3157 or placebo in healthy male Japanese participants
Group 2BEXPERIMENTAL300 mg CNTO 3157 or placebo in healthy male Caucasian participants
Group 3AEXPERIMENTAL600 mg CNTO 3157 or placebo in healthy male Japanese participants
Group 3BEXPERIMENTAL600 mg CNTO 3157 or placebo in healthy male Caucasian participants
Group 4EXPERIMENTAL300 mg CNTO 3157 in healthy male Caucasian participants
Interventions
NameTypeDescription
100 mg CNTO 3157BIOLOGICALA single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
300 mg CNTO 3157BIOLOGICAL2 SC injections of CNTO 3157 providing a total dose of 300 mg
600 mg CNTO 3157BIOLOGICAL4 SC injections of CNTO 3157 providing a total dose of 600 mg
PlaceboDRUGSC injections of placebo (number of injections to equal number of injections of CNTO 3157)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
Unlock Eligibility Criteria