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

NCT02008279 | Completed Phase 1

• 2 other identifiers: CR102823CNTO3175NAP1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; CNTO 3157; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (7)

Group 1A

EXPERIMENTAL

100 mg CNTO 3157 or placebo in healthy male Japanese participants

Biological: 100 mg CNTO 3157; Drug: Placebo

Group 1B

EXPERIMENTAL

100 mg CNTO 3157 or placebo in healthy male Caucasian participants

Biological: 100 mg CNTO 3157; Drug: Placebo

Group 2A

EXPERIMENTAL

300 mg CNTO 3157 or placebo in healthy male Japanese participants

Biological: 300 mg CNTO 3157; Drug: Placebo

Group 2B

EXPERIMENTAL

300 mg CNTO 3157 or placebo in healthy male Caucasian participants

Biological: 300 mg CNTO 3157; Drug: Placebo

Group 3A

EXPERIMENTAL

600 mg CNTO 3157 or placebo in healthy male Japanese participants

Biological: 600 mg CNTO 3157; Drug: Placebo

Group 3B

EXPERIMENTAL

600 mg CNTO 3157 or placebo in healthy male Caucasian participants

Biological: 600 mg CNTO 3157; Drug: Placebo

Group 4

EXPERIMENTAL

300 mg CNTO 3157 in healthy male Caucasian participants

Biological: 300 mg CNTO 3157

Interventions

100 mg CNTO 3157 BIOLOGICAL

A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157

Group 1A; Group 1B

300 mg CNTO 3157 BIOLOGICAL

2 SC injections of CNTO 3157 providing a total dose of 300 mg

Group 2A; Group 2B

600 mg CNTO 3157 BIOLOGICAL

4 SC injections of CNTO 3157 providing a total dose of 600 mg

Group 3A; Group 3B

Placebo DRUG

SC injections of placebo (number of injections to equal number of injections of CNTO 3157)

Group 1A; Group 1B; Group 2A; Group 2B; Group 3A; Group 3B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

US (1)