HealthyPhase 1NCT01288196
A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers
A Phase 1 study testing CNTO 6785 1 mg/kg IV, CNTO 6785 3 mg/kg IV and CNTO 6785 10 mg/kg IV in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CNTO 6785 1 mg/kg IV, CNTO 6785 3 mg/kg IV and CNTO 6785 10 mg/kg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Aug 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
- Have a body mass index (BMI) between 19-30 kg/m2
- Be a non-smoker for at least 6 months prior to study participation
- Women must be postmenopausal or surgically sterile
Who cannot join
- Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
- Major surgery or significant trauma within 12 weeks of screening
- Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
- Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CNTO 6785 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.
Read the detailed description
This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
- Conditions
- Healthy
- Being tested
- Placebo IV, CNTO 6785 1 mg/kg IV, CNTO 6785 3 mg/kg IV, CNTO 6785 10 mg/kg IV, CNTO 6785 SC
- Keywords
- CNTO 6785, Intravenous, Subcutaneous, Pharmacokinetics, Immunogenicity, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo IVDrug
A single 30-minute IV infusion of placebo
CNTO 6785 1 mg/kg IVDrug
A single 30-minute IV infusion of CNTO 6785 1 mg/kg
CNTO 6785 3 mg/kg IVDrug
A single 30-minute IV infusion of CNTO 6785 3 mg/kg
CNTO 6785 10 mg/kg IVDrug
A single 30-minute IV infusion of CNTO 6785 10 mg/kg
CNTO 6785 SCDrug
A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
Placebo SCDrug
A single SC dose of placebo administered in up to 3 SC injections
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg Receives: Drug: CNTO 6785 1 mg/kg IV |
| 002 | Experimental | CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg Receives: Drug: CNTO 6785 3 mg/kg IV |
| 003 | Experimental | CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg Receives: Drug: CNTO 6785 10 mg/kg IV |
| 004 | Placebo comparator | Placebo IV A single 30-minute IV infusion of placebo Receives: Drug: Placebo IV |
| 005 | Experimental | CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections Receives: Drug: CNTO 6785 SC |
| 006 | Placebo comparator | Placebo SC A single SC dose of placebo administered in up to 3 SC injections Receives: Drug: Placebo SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of adverse events reported
Measured: Up to Week 17
Number and type of Infusion (injection) site reactions
Measured: Up to Week 17
Vital signs measurements
Measured: Up to Week 17
Clinical laboratory test results
Measured: Up to Week 17
Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)
Measured: Up to Week 17
Secondary outcomes (2)
Serum concentration of CNTO 6785
Measured: Up to Week 17
Serum antibodies to CNTO 6785
Measured: Up to Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288196
- Sponsor's protocol ID
- CR017752
- Other IDs
- CNTO6785OPD1001
- Status last verified
- Jan 2013
- First submitted
- 1 Feb 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CNTO 6785 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01288196
- Acronym / sponsor ID
- CR017752
- Conditions
- Healthy
- Keywords
- CNTO 6785, Intravenous, Subcutaneous, Pharmacokinetics, Immunogenicity, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Feb 2011 (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, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.
Detailed description
This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: CNTO 6785 1 mg/kg IVCNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg |
| 002 | Experimental | Drug: CNTO 6785 3 mg/kg IVCNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg |
| 003 | Experimental | Drug: CNTO 6785 10 mg/kg IVCNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg |
| 004 | Placebo comparator | Drug: Placebo IVPlacebo IV A single 30-minute IV infusion of placebo |
| 005 | Experimental | Drug: CNTO 6785 SCCNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections |
| 006 | Placebo comparator | Drug: Placebo SCPlacebo SC A single SC dose of placebo administered in up to 3 SC injections |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
- Have a body mass index (BMI) between 19-30 kg/m2
- Be a non-smoker for at least 6 months prior to study participation
- Women must be postmenopausal or surgically sterile
Key exclusion criteria (4 listed)
- Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
- Major surgery or significant trauma within 12 weeks of screening
- Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
- Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).
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 |
|---|---|---|
| Placebo IVA single 30-minute IV infusion of placebo | Drug | 004 |
| CNTO 6785 1 mg/kg IVA single 30-minute IV infusion of CNTO 6785 1 mg/kg | Drug | 001 |
| CNTO 6785 3 mg/kg IVA single 30-minute IV infusion of CNTO 6785 3 mg/kg | Drug | 002 |
| CNTO 6785 10 mg/kg IVA single 30-minute IV infusion of CNTO 6785 10 mg/kg | Drug | 003 |
| CNTO 6785 SCA single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections | Drug | 005 |
| Placebo SCA single SC dose of placebo administered in up to 3 SC injections | Drug | 006 |
Primary outcome
Number and type of adverse events reported
Time frame: Up to Week 17
Number and type of Infusion (injection) site reactions
Time frame: Up to Week 17
Vital signs measurements
Time frame: Up to Week 17
Clinical laboratory test results
Time frame: Up to Week 17
Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)
Time frame: Up to Week 17
2 secondary outcomes
Serum concentration of CNTO 6785
Time frame: Up to Week 17
Serum antibodies to CNTO 6785
Time frame: Up to Week 17
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 28 Jan 2013.
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNTO 6785 1 mg/kg IV, CNTO 6785 3 mg/kg IV and CNTO 6785 10 mg/kg IV in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
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 4 inclusion and 4 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 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Number and type of adverse events reported (time frame: Up to Week 17). The study lists 5 primary outcomes in all. 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 28 Jan 2013.