HealthyPhase 1NCT02008279
A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
A Phase 1 study testing 100 mg CNTO 3157, 300 mg CNTO 3157 and 600 mg CNTO 3157 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 100 mg CNTO 3157, 300 mg CNTO 3157 and 600 mg CNTO 3157
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Aug 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Who cannot join
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
Read the detailed description
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men. Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion. The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center). During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo. Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157. Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level. The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner. An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B). Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo. Only Caucasian participants will be enrolled in the IV treatment group (group 4). For each treatment group, blood and urine samples will be taken at various time points during the study. Each participant will take part in the study for approximately 85 days. Participant safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- 100 mg CNTO 3157, 300 mg CNTO 3157, 600 mg CNTO 3157, Placebo
- Keywords
- Healthy, CNTO 3157, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg CNTO 3157Biological
A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
300 mg CNTO 3157Biological
2 SC injections of CNTO 3157 providing a total dose of 300 mg
600 mg CNTO 3157Biological
4 SC injections of CNTO 3157 providing a total dose of 600 mg
300 mg CNTO 3157Biological
300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
PlaceboDrug
SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | 100 mg CNTO 3157 or placebo in healthy male Japanese participants Receives: Biological: 100 mg CNTO 3157; Drug: Placebo |
| Group 1B | Experimental | 100 mg CNTO 3157 or placebo in healthy male Caucasian participants Receives: Biological: 100 mg CNTO 3157; Drug: Placebo |
| Group 2A | Experimental | 300 mg CNTO 3157 or placebo in healthy male Japanese participants Receives: Biological: 300 mg CNTO 3157; Drug: Placebo |
| Group 2B | Experimental | 300 mg CNTO 3157 or placebo in healthy male Caucasian participants Receives: Biological: 300 mg CNTO 3157; Drug: Placebo |
| Group 3A | Experimental | 600 mg CNTO 3157 or placebo in healthy male Japanese participants Receives: Biological: 600 mg CNTO 3157; Drug: Placebo |
| Group 3B | Experimental | 600 mg CNTO 3157 or placebo in healthy male Caucasian participants Receives: Biological: 600 mg CNTO 3157; Drug: Placebo |
| Group 4 | Experimental | 300 mg CNTO 3157 in healthy male Caucasian participants Receives: Biological: 300 mg CNTO 3157 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
Measured: Up to Day 57
Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
Measured: Up to Day 57
Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
Measured: Up to Day 57
Secondary outcomes (2)
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
Measured: Up to Day 57
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008279
- Sponsor's protocol ID
- CR102823
- Other IDs
- CNTO3175NAP1001
- Status last verified
- Sep 2014
- First submitted
- 6 Dec 2013
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of CNTO3157 Following an Escalating Single SC Dose to Healthy Japanese and Caucasian Subjects or a Single Intravenous Dose to Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT02008279
- Acronym / sponsor ID
- CR102823
- Conditions
- Healthy
- Keywords
- Healthy, CNTO 3157, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 2013 (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 find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.
Detailed description
This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men. Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion. The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center). During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo. Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157. Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level. The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner. An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B). Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo. Only Caucasian participants will be enrolled in the IV treatment group (group 4). For each treatment group, blood and urine samples will be taken at various time points during the study. Each participant will take part in the study for approximately 85 days. Participant safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Biological: 100 mg CNTO 3157, Drug: Placebo100 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 1B | Experimental | Biological: 100 mg CNTO 3157, Drug: Placebo100 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 2A | Experimental | Biological: 300 mg CNTO 3157, Drug: Placebo300 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 2B | Experimental | Biological: 300 mg CNTO 3157, Drug: Placebo300 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 3A | Experimental | Biological: 600 mg CNTO 3157, Drug: Placebo600 mg CNTO 3157 or placebo in healthy male Japanese participants |
| Group 3B | Experimental | Biological: 600 mg CNTO 3157, Drug: Placebo600 mg CNTO 3157 or placebo in healthy male Caucasian participants |
| Group 4 | Experimental | Biological: 300 mg CNTO 3157300 mg CNTO 3157 in healthy male Caucasian participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must have a screening body weight in the range of 50 kg to 100 kg, inclusive, and a screening body mass index of 18.5 kg/m2 to 30 kg/m2, inclusive
- Participants must be: of Japanese descent whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report; Japanese participants must have valid government issued identification; Japanese participants must have resided outside of Japan for <= 5 years; or must be of non-Hispanic Caucasian descent whose parents are Caucasian, as determined by participant's verbal report
- Participants must have been exposed to herpes simplex-type 1 virus (HSV-1) as documented by a positive serology test result for HSV-1 performed at screening, but have no signs or symptoms suggestive of an active HSV-1 infection and are not receiving prescription treatment or prophylaxis for HSV-1
Key exclusion criteria (5 listed)
- Participant has or has had a clinically significant (viral, bacterial or parasitic) infection, a prior history of recurrent serious infection (eg, sepsis, pneumonia or pyelonephritis) or be immunosuppressed or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening
- Participant is infected with human immunodeficiency virus or tests positive for hepatitis B virus infection or has antibodies to hepatitis C virus at screening
- Participant has received any live or attenuated virus or bacterial vaccinations within 3 months prior to study agent administration or is expected to receive any live virus or bacterial vaccinations during the study or up to 6 months after administration of the study agent
- Participant has had major surgery, (eg, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study OR has had a major illness or hospitalization within 1 month prior to study agent administration
- Participant has a history of, or currently active illness/disorder, considered to be clinically significant by the Investigator or any other illness/disorder that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results
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 |
|---|---|---|
| 100 mg CNTO 3157A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157 | Biological | Group 1A, Group 1B |
| 300 mg CNTO 31572 SC injections of CNTO 3157 providing a total dose of 300 mg | Biological | Group 2A, Group 2B |
| 600 mg CNTO 31574 SC injections of CNTO 3157 providing a total dose of 600 mg | Biological | Group 3A, Group 3B |
| 300 mg CNTO 3157300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes | Biological | Group 4 |
| PlaceboSC injections of placebo (number of injections to equal number of injections of CNTO 3157) | Drug | Group 1A, Group 1B, Group 2A, Group 2B, Group 3A, Group 3B |
Primary outcome
Frequency of adverse events
Time frame: Up to Day 57
The frequency of adverse events will be used to assess the safety and tolerability of CNTO 3157.
Serum concentrations of CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Time frame: Up to Day 57
Serum concentrations of CNTO 3157 will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug).
Titer (concentration) of antibodies to CNTO 3157 in Caucasian and Japanese participants following single subcutaneous doses of 100 mg, 300 mg, and 600 mg
Time frame: Up to Day 57
Serum samples will be screened for antibodies binding to CNTO 3157 providing an indication of the ability of CNTO 3157 to cause an immune response.
2 secondary outcomes
Serum concentrations of CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Time frame: Up to Day 57
Titer (concentration) of antibodies to CNTO 3157 in Caucasian participants following a single intravenous infusion of 300 mg
Time frame: Up to Day 57
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 30 Sep 2014.
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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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 100 mg CNTO 3157, 300 mg CNTO 3157 and 600 mg CNTO 3157 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 3 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 30 Sep 2014. 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 United States. 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?
Frequency of adverse events (time frame: Up to Day 57). The study lists 3 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 30 Sep 2014.