AsthmaPhase 1NCT01195207
A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma
A Phase 1 study of Asthma, run by Centocor, Inc. at 4 sites in 3 countries.
Trial summary
This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2010to Jan 2012
- 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 male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
- Patients with asthma must have been diagnosed at least 6 months prior to participation in the study
Who cannot join
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Have a positive pregnancy test at screening or prior to dose administration
- Have smoked tobacco or related products within 6 months prior to dosing
- Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
- Recent history (within previous 6 months) of alcohol or drug abuse
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Intravenous Study in Healthy Subjects and a Multiple-Dose Intravenous Study in Asthmatic Subjects to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of CNTO 3157
This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.
Read the detailed description
A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 3157, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). 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. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic patients will take part. Volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157 will be administered by IV infusion. The duration of volunteer participation will be up to 21 weeks in Part 1 and up to 24 weeks in Part 2.
- Conditions
- Asthma
- Being tested
- CNTO 3157 or placebo
- Keywords
- CNTO 3157, healthy volunteers, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 3157 or placeboBiological
0.003 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
0.03 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
10 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
0.01 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
1 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
3 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
0.3 mg/kg CNTO 3157 or placebo infusion
CNTO 3157 or placeboBiological
0.1 mg/kg CNTO 3157 or placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 002 | Experimental | CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 003 | Experimental | CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 004 | Experimental | CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 005 | Experimental | CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 006 | Experimental | CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 007 | Experimental | CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
| 008 | Experimental | CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion Receives: Biological: CNTO 3157 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CNTO 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events
Measured: Week 21 for Part 1 and Week 24 for Part 2
Secondary outcomes (3)
Evaluate the effects of CNTO3157 on the body and the effects of the body on CNTO 3157 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Measured: Week 21 for Part 1 and Week 24 for Part 2
Immune response (Immunogenicity)
Measured: Week 21 for Part 1 and Week 24 for Part 2
Clinical Response
Measured: Week 21 for Part 1 and Week 24 for Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startJun 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195207
- Sponsor's protocol ID
- CR017095
- Status last verified
- Nov 2012
- First submitted
- 2 Sep 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Intravenous Study in Healthy Subjects and a Multiple-Dose Intravenous Study in Asthmatic Subjects to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of CNTO 3157
- ClinicalTrials.gov ID
- NCT01195207
- Acronym / sponsor ID
- CR017095
- Conditions
- Asthma
- Keywords
- CNTO 3157, healthy volunteers, asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Sep 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.
This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.
Detailed description
A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 3157, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). 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. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic patients will take part. Volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157 will be administered by IV infusion. The duration of volunteer participation will be up to 21 weeks in Part 1 and up to 24 weeks in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion |
| 002 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion |
| 003 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion |
| 004 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion |
| 005 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion |
| 006 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion |
| 007 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion |
| 008 | Experimental | Biological: CNTO 3157 or placeboCNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
- Patients with asthma must have been diagnosed at least 6 months prior to participation in the study
Key exclusion criteria (5 listed)
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Have a positive pregnancy test at screening or prior to dose administration
- Have smoked tobacco or related products within 6 months prior to dosing
- Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
- Recent history (within previous 6 months) of alcohol or drug abuse
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 3157 or placebo0.003 mg/kg CNTO 3157 or placebo infusion | Biological | 001 |
| CNTO 3157 or placebo0.03 mg/kg CNTO 3157 or placebo infusion | Biological | 003 |
| CNTO 3157 or placebo10 mg/kg CNTO 3157 or placebo infusion | Biological | 008 |
| CNTO 3157 or placebo0.01 mg/kg CNTO 3157 or placebo infusion | Biological | 002 |
| CNTO 3157 or placebo1 mg/kg CNTO 3157 or placebo infusion | Biological | 006 |
| CNTO 3157 or placebo3 mg/kg CNTO 3157 or placebo infusion | Biological | 007 |
| CNTO 3157 or placebo0.3 mg/kg CNTO 3157 or placebo infusion | Biological | 005 |
| CNTO 3157 or placebo0.1 mg/kg CNTO 3157 or placebo infusion | Biological | 004 |
Primary outcome
Safety and tolerability of CNTO 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events
Time frame: Week 21 for Part 1 and Week 24 for Part 2
3 secondary outcomes
Evaluate the effects of CNTO3157 on the body and the effects of the body on CNTO 3157 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Time frame: Week 21 for Part 1 and Week 24 for Part 2
Immune response (Immunogenicity)
Time frame: Week 21 for Part 1 and Week 24 for Part 2
Clinical Response
Time frame: Week 21 for Part 1 and Week 24 for Part 2
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 Nov 2012.
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Asthma, run by Centocor, Inc. at 4 sites in 3 countries.
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 2 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, United Kingdom. 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. 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 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events (time frame: Week 21 for Part 1 and Week 24 for Part 2). 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 Nov 2012.