HealthyPhase 1NCT00844909
A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers
A Phase 1 study testing CNTO 136 in people with Healthy, run by Centocor, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CNTO 136
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of CNTO136 Following a Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects.
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.
- Conditions
- Healthy
- Being tested
- CNTO 136
- Keywords
- CNTO 136, safety, pharmacokinetics, healthy Japanese, healthy Caucasian, Phase I, antibody, male.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 136Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startJan 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844909
- Sponsor's protocol ID
- CR015910
- Status last verified
- Oct 2009
- First submitted
- 13 Feb 2009
- Last updated
- 27 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of CNTO136 Following a Single Subcutaneous Administration to Healthy Japanese and Caucasian Subjects.
- ClinicalTrials.gov ID
- NCT00844909
- Acronym / sponsor ID
- CR015910
- Conditions
- Healthy
- Keywords
- CNTO 136, safety, pharmacokinetics, healthy Japanese, healthy Caucasian, Phase I, antibody, male.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTO 136 | Drug | – |
Primary outcome
Safety and tolerability of a single SC administration of CNTO 136 in healthy Japanese and Caucasian volunteers
1 secondary outcome
Pharmacokinetics and immunogenicity of a single SC administration of CNTO 136.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 136 in people with Healthy, run by Centocor, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of a single SC administration of CNTO 136 in healthy Japanese and Caucasian volunteers. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.