A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: 100 mg CNTO 3157; Drug: Placebo; Biological: 300 mg CNTO 3157; Biological: 300 mg CNTO 3157; Biological: 600 mg CNTO 3157

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
• Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1

Exclusion Criteria:

• Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
• Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
• Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
• Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
• Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1A; 100 mg CNTO 3157 or placebo in healthy male Japanese participants	Biological: 100 mg CNTO 3157; A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157; Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
Experimental: Group 1B; 100 mg CNTO 3157 or placebo in healthy male Caucasian participants	Biological: 100 mg CNTO 3157; A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157; Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
Experimental: Group 2A; 300 mg CNTO 3157 or placebo in healthy male Japanese participants	Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157); Biological: 300 mg CNTO 3157; 2 SC injections of CNTO 3157 providing a total dose of 300 mg; Biological: 300 mg CNTO 3157; 300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
Experimental: Group 2B; 300 mg CNTO 3157 or placebo in healthy male Caucasian participants	Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157); Biological: 300 mg CNTO 3157; 2 SC injections of CNTO 3157 providing a total dose of 300 mg; Biological: 300 mg CNTO 3157; 300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
Experimental: Group 3A; 600 mg CNTO 3157 or placebo in healthy male Japanese participants	Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157); Biological: 600 mg CNTO 3157; 4 SC injections of CNTO 3157 providing a total dose of 600 mg
Experimental: Group 3B; 600 mg CNTO 3157 or placebo in healthy male Caucasian participants	Drug: Placebo; SC injections of placebo (number of injections to equal number of injections of CNTO 3157); Biological: 600 mg CNTO 3157; 4 SC injections of CNTO 3157 providing a total dose of 600 mg
Experimental: Group 4; 300 mg CNTO 3157 in healthy male Caucasian participants	Biological: 300 mg CNTO 3157; 2 SC injections of CNTO 3157 providing a total dose of 300 mg; Biological: 300 mg CNTO 3157; 300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Healthy; Pharmacokinetics; CNTO 3157
• Other Study ID Numbers: CR102823; CNTO3175NAP1001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No