HealthyPhase 1NCT02074800
A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants
A Phase 1 study testing CNTO 328 (Sp2/0-derived) and CNTO 328 (CHO-derived) in people with Healthy, run by Centocor, Inc. at 2 sites in United States.
Trial summary
The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CNTO 328 (Sp2/0-derived) and CNTO 328 (CHO-derived)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically relevant abnormalities as determined by medical history, physical examination, blood parameters and having Body Mass Index (BMI) between 18.5 to 27 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Have an absolute neutrophil count of 2000 or more per cube millimeter at screening and one day before the study medication administration
- Agree to use adequate birth control measures for at least 100 days after study medication administration
- Agree not to use prescription medications (with the exception of hormonal contraceptives) within 14 days prior to study medication administration and through Day 85 of the study, unless approved by medical monitor
- Agree to limit caffeine/xanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) intake to less than 300 mg/day through Day 85 of the study
Who cannot join
- Have a current or past 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 a current or past history of thrombocytopenia (a low platelet count) or bleeding abnormality or elevations in triglycerides that require treatment
- Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
- Positive serology test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening
- Positive urine toxicology screen and substances of abuse, including but not limited to alcohol, cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Lincoln, Nebraska
Study site
Neptune City, New Jersey
About this study
Official title: A Phase 1, Randomized Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Subjects
The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
Read the detailed description
This is a single-dose and randomized (study medication is assigned by chance) study. This study will be conducted in 2 parts (Part 1 and Part 2). Approximately 144 participants will be enrolled in this study (24 participants in Part 1 and 120 participants in Part 2). Part 1 is the double-blind (neither physician nor participants know the treatment that the participant receives) and staggered parallel (a clinical study comparing the response in two or more groups of participants receiving different treatments) part of the study. Participants in Part 1 will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. Part 2 is the open-label (all people know the identity of the intervention) part of the study. Participants in Part 2 will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 199 days including a screening phase (within 30 days before the first study medication administration) and a treatment phase (inpatient [hospitalization period] 12 days and outpatient [follow-up] visits up to 169 days).
- Conditions
- Healthy
- Being tested
- CNTO 328 (Sp2/0-derived), CNTO 328 (CHO-derived), Placebo
- Keywords
- Healthy, CNTO 328, Sp2/0-derived CNTO 328, CHO-derived CNTO 328, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 328 (Sp2/0-derived)Drug
Also called SILTUXIMAB
Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.
CNTO 328 (CHO-derived)Drug
Also called SILTUXIMAB
Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.
PlaceboDrug
Participants will receive a single-dose of matching placebo intravenously in Part 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. Receives: Drug: CNTO 328 (Sp2/0-derived); Drug: CNTO 328 (CHO-derived); Drug: Placebo |
| Part 2 | Experimental | Participants will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. Receives: Drug: CNTO 328 (Sp2/0-derived); Drug: CNTO 328 (CHO-derived) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability in Part 1
Measured: Up to Day 199
Maximum observed serum concentration (Cmax) of CNTO 328 in Part 2
This sample will be used for pharmacokinetics analysis. Cmax is defined as the maximum observed analyte concentration.
Measured: Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85
Area under the serum concentration-time curve from Day 0 to Day 84 (AUC 0-84D) of CNTO 328 in Part 2
This sample will be used for pharmacokinetics analysis. AUC 0-84D is a measure of the serum concentration of the study medication over time. It is used to characterize drug absorption.
Measured: Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85
Secondary outcomes (2)
Number of participants with adverse events as a measure of safety and tolerability in Part 2
Measured: Up to Day 199
Immune response of CNTO 328 in Part 1 and Part 2
Immune response will be evaluated by analyzing serum samples for the determination of the presence of antibodies to CNTO 328.
Measured: Day 1 (predose), Days 85, 113, and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074800
- Sponsor's protocol ID
- CR015271
- Other IDs
- C0328T08
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2014
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02074800
- Acronym / sponsor ID
- CR015271
- Conditions
- Healthy
- Keywords
- Healthy, CNTO 328, Sp2/0-derived CNTO 328, CHO-derived CNTO 328, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Feb 2014 (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 Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
Detailed description
This is a single-dose and randomized (study medication is assigned by chance) study. This study will be conducted in 2 parts (Part 1 and Part 2). Approximately 144 participants will be enrolled in this study (24 participants in Part 1 and 120 participants in Part 2). Part 1 is the double-blind (neither physician nor participants know the treatment that the participant receives) and staggered parallel (a clinical study comparing the response in two or more groups of participants receiving different treatments) part of the study. Participants in Part 1 will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. Part 2 is the open-label (all people know the identity of the intervention) part of the study. Participants in Part 2 will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 199 days including a screening phase (within 30 days before the first study medication administration) and a treatment phase (inpatient [hospitalization period] 12 days and outpatient [follow-up] visits up to 169 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: CNTO 328 (Sp2/0-derived), Drug: CNTO 328 (CHO-derived), Drug: PlaceboParticipants will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. |
| Part 2 | Experimental | Drug: CNTO 328 (Sp2/0-derived), Drug: CNTO 328 (CHO-derived)Participants will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- No clinically relevant abnormalities as determined by medical history, physical examination, blood parameters and having Body Mass Index (BMI) between 18.5 to 27 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
- Have an absolute neutrophil count of 2000 or more per cube millimeter at screening and one day before the study medication administration
- Agree to use adequate birth control measures for at least 100 days after study medication administration
- Agree not to use prescription medications (with the exception of hormonal contraceptives) within 14 days prior to study medication administration and through Day 85 of the study, unless approved by medical monitor
- Agree to limit caffeine/xanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) intake to less than 300 mg/day through Day 85 of the study
Key exclusion criteria (5 listed)
- Have a current or past 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 a current or past history of thrombocytopenia (a low platelet count) or bleeding abnormality or elevations in triglycerides that require treatment
- Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
- Positive serology test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening
- Positive urine toxicology screen and substances of abuse, including but not limited to alcohol, cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone
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 328 (Sp2/0-derived)Also: SILTUXIMABParticipants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2. | Drug | Part 1, Part 2 |
| CNTO 328 (CHO-derived)Also: SILTUXIMABParticipants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2. | Drug | Part 1, Part 2 |
| PlaceboParticipants will receive a single-dose of matching placebo intravenously in Part 1. | Drug | Part 1 |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability in Part 1
Time frame: Up to Day 199
Maximum observed serum concentration (Cmax) of CNTO 328 in Part 2
Time frame: Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85
This sample will be used for pharmacokinetics analysis. Cmax is defined as the maximum observed analyte concentration.
Area under the serum concentration-time curve from Day 0 to Day 84 (AUC 0-84D) of CNTO 328 in Part 2
Time frame: Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85
This sample will be used for pharmacokinetics analysis. AUC 0-84D is a measure of the serum concentration of the study medication over time. It is used to characterize drug absorption.
2 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability in Part 2
Time frame: Up to Day 199
Immune response of CNTO 328 in Part 1 and Part 2
Time frame: Day 1 (predose), Days 85, 113, and 169
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 5 Feb 2015.
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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 Clinical Trial study director
Centocor, Inc.
2 sites 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 328 (Sp2/0-derived) and CNTO 328 (CHO-derived) in people with Healthy, run by Centocor, Inc. at 2 sites 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 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 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of participants with adverse events as a measure of safety and tolerability in Part 1 (time frame: Up to Day 199). 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 5 Feb 2015.