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CompletedNCT00844909Updated Apr 27, 2010

A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers

A Phase 1 interventional study of CNTO 136 in Healthy, sponsored by Centocor, Inc.. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-27.

Sponsored by Centocor, Inc. (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the safety, tolerability and how the body affects the drug CNTO 136 in healthy Japanese and Caucasian volunteers.

Read the detailed description

This is a randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of CNTO 136. In a randomized trial, study medication (CNTO 136 or placebo) is assigned by chance. Double-blinded means that neither the investigator nor the volunteer know which of the study medication they have been assigned to receive. Pharmacokinetics is the study of levels of CNTO 136 circulating in your blood over time. The study population will all be male and consist of 30 Japanese and 30 Caucasian volunteers. Three dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then required to return for out-patient visits. One of 3 dose levels of CNTO 136 will be given just under the skin (subcutaneous (SC)). The length of this study will be about 20 weeks.

02

Conditions studied

  • Healthy

Keywords

  • CNTO 136
  • safety
  • pharmacokinetics
  • healthy Japanese
  • healthy Caucasian
  • Phase I
  • antibody
  • male.
03

In context

Lead sponsor

Centocor, Inc. is the lead sponsor of 75 studies on the registry; none are open to participants now.

First submitted after Centocor, Inc. became part of Johnson & Johnson.

Browse Centocor, Inc. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Demonstrate an understanding of the study and sign an informed consent form
  • Healthy with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count (CBC), coagulation tests, urinalysis, measurement of vital signs, and ECG
  • Japanese volunteers must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents. Caucasian subjects must have Caucasian parents
  • Have a weight in the range of 60 kg to 90 kg (inclusive), body mass index (BMI) of 19 kg/m2 to 29 kg/m2
  • Nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

Exclusion criteria

Exclusion Criteria:

  • Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the investigator
  • Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the healthy volunteer will complete the study
  • Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
  • Currently have any known malignancy or have a history of malignancy
  • Have had major or traumatic surgery within 12 weeks of screening or any surgery within 1 week.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
62 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of a single SC administration of CNTO 136 in healthy Japanese and Caucasian volunteers

Secondary outcomes

  1. Pharmacokinetics and immunogenicity of a single SC administration of CNTO 136.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2009 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2009
First posted
Feb 16, 2009
Start
Jan 2009
CompletionActual
Aug 2009
Last update
Apr 27, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00844909
Lead sponsor
Centocor, Inc.
First posted
Feb 16, 2009
Start date
Jan 2009
Completion
Aug 2009
Last update
Apr 27, 2010

Study contacts

Centocor, Inc. Clinical Trial
study director · Centocor, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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