HealthyPhase 1NCT01081691
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
A Phase 1 study testing CNTO 5825 in people with Healthy, run by Centocor, Inc..
Trial summary
The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy 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 5825
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2010
- 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 man or woman with no clinically significant abnormalities
- Body weight in the range of 50 to 100 kg inclusive
- Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
- For healthy atopic patients: history of atopic allergy
Who cannot join
- Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
- Received an experimental antibody or biologic therapy within the previous 6 months
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 5825 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.
Read the detailed description
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five 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 return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.
- Conditions
- Healthy
- Being tested
- CNTO 5825
- Keywords
- CNTO 5825, Safety, Phase I, Healthy adults, Healthy Atopic adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 5825Biological
10 mg/kg single dose IV or matching placebo
CNTO 5825Biological
3 mg/kg single dose IV or matching placebo
CNTO 5825Biological
For atopic patient:10 mg/kg single IV dose or matching placebo
CNTO 5825Biological
For atopic patient: 3 mg/kg single dose SC or matching placebo
CNTO 5825Biological
0.3 mg/kg single dose IV or matching placebo
CNTO 5825Biological
0.1 mg/kg single dose Intravenously (IV) or matching placebo
CNTO 5825Biological
1 mg/kg single dose IV or matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo Receives: Biological: CNTO 5825 |
| 002 | Experimental | CNTO 5825 0.3 mg/kg single dose IV or matching placebo Receives: Biological: CNTO 5825 |
| 003 | Experimental | CNTO 5825 1 mg/kg single dose IV or matching placebo Receives: Biological: CNTO 5825 |
| 004 | Experimental | CNTO 5825 3 mg/kg single dose IV or matching placebo Receives: Biological: CNTO 5825 |
| 005 | Experimental | CNTO 5825 10 mg/kg single dose IV or matching placebo Receives: Biological: CNTO 5825 |
| 006 | Experimental | CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo Receives: Biological: CNTO 5825 |
| 007 | Experimental | CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo Receives: Biological: CNTO 5825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers.
Measured: 17 weeks post dose
Secondary outcomes (2)
Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Measured: 17 weeks post dose
Immune response (Immunogenicity) after dose with CNTO 5825
Measured: 17 weeks post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startFeb 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 64 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
- NCT01081691
- Sponsor's protocol ID
- CR015574
- Other IDs
- EudraCT No.: 2009-013343-11
- Status last verified
- Sep 2010
- First submitted
- 18 Feb 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
Publications
van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.
PubMed 23043368
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 5825 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01081691
- Acronym / sponsor ID
- CR015574
- Conditions
- Healthy
- Keywords
- CNTO 5825, Safety, Phase I, Healthy adults, Healthy Atopic adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Mar 2010 (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 assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.
Detailed description
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five 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 return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Biological: CNTO 5825CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo |
| 002 | Experimental | Biological: CNTO 5825CNTO 5825 0.3 mg/kg single dose IV or matching placebo |
| 003 | Experimental | Biological: CNTO 5825CNTO 5825 1 mg/kg single dose IV or matching placebo |
| 004 | Experimental | Biological: CNTO 5825CNTO 5825 3 mg/kg single dose IV or matching placebo |
| 005 | Experimental | Biological: CNTO 5825CNTO 5825 10 mg/kg single dose IV or matching placebo |
| 006 | Experimental | Biological: CNTO 5825CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo |
| 007 | Experimental | Biological: CNTO 5825CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy man or woman with no clinically significant abnormalities
- Body weight in the range of 50 to 100 kg inclusive
- Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
- For healthy atopic patients: history of atopic allergy
Key exclusion criteria (2 listed)
- Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
- Received an experimental antibody or biologic therapy within the previous 6 months
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 582510 mg/kg single dose IV or matching placebo | Biological | 005 |
| CNTO 58253 mg/kg single dose IV or matching placebo | Biological | 004 |
| CNTO 5825For atopic patient:10 mg/kg single IV dose or matching placebo | Biological | 006 |
| CNTO 5825For atopic patient: 3 mg/kg single dose SC or matching placebo | Biological | 007 |
| CNTO 58250.3 mg/kg single dose IV or matching placebo | Biological | 002 |
| CNTO 58250.1 mg/kg single dose Intravenously (IV) or matching placebo | Biological | 001 |
| CNTO 58251 mg/kg single dose IV or matching placebo | Biological | 003 |
Primary outcome
Safety and tolerability of CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers.
Time frame: 17 weeks post dose
2 secondary outcomes
Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Time frame: 17 weeks post dose
Immune response (Immunogenicity) after dose with CNTO 5825
Time frame: 17 weeks post dose
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 1 Oct 2010.
- Derived from this study: PubMed 23043368van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.
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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 5825 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 4 inclusion and 2 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 1 Oct 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 CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers. (time frame: 17 weeks post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081691, which also lists 1 linked publication.
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 1 Oct 2010; AzTrials last refreshed its copy on 6 Nov 2026.