HealthyPhase 1NCT03047317
A Pharmacokinetic Study of MABp1 in Healthy Volunteers
A Phase 1 study testing MABp1 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MABp1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 31 Mar 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18
- Adequate bone marrow function as defined as:
- absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
- platelet count > 150,000/mm3
- hemoglobin of ≥ 10 g/dL
- Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
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- Adequate hepatic function defined as:
- total bilirubin ≤ 1.5 times lab ULN.
- alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
- For WOCBP, a negative pregnancy test at screening. For subjects with reproductive potential, a willingness to utilize contraception during the study and for at least 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and for at least 3 months after study completion.
- Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.
Who cannot join
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within the past 6 months.
- Uncontrolled angina within the past 3 months.
- Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Classes II or higher.
- Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic).
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- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- Infectious disease:
- CRP >30 mg/L, or infection requiring treatment with antibiotics within 3 weeks prior to Screening,
- Positive HIV, RPR, Hepatitis C antibody, or IGRA
- Immunodeficiency by history.
- Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
- Major surgery within 28 days prior to Day 0.
- WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to randomization, for the duration of the study, and for at least 3 months after the last dose of study medication.
- History of progressive multifocal leukoencephalopathy or other demyelinating disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Pharmacokinetic Study of MABp1 in Healthy Volunteers
This is an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.
- Conditions
- Healthy
- Being tested
- MABp1
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MABp1Biological
Single dose of intravenous MABp1
| Study group | Role | What they receive |
|---|---|---|
| MABp1 | Experimental | Not described Receives: Biological: MABp1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration
Pharmacokinetics--blood levels of MABp1 antibody
Measured: 2 weeks
Time to Peak Plasma Concentration
Pharmacokinetics--blood levels of MABp1 antibody
Measured: 2 weeks
Half Life
Pharmacokinetics--blood levels of MABp1 antibody
Measured: 2 weeks
Area under the plasma concentration versus time curve
Pharmacokinetics--blood levels of MABp1 antibody
Measured: 2 weeks
Secondary outcomes (1)
Incidence of treatment emergent adverse events
The occurrence and incidence of treatment emergent adverse events will be recorded.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion8 Mar 2017
- Study completion31 Mar 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Stecher, MD, Study director, XBiotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047317
- Sponsor's protocol ID
- 2017-PT041
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2017
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacokinetic Study of MABp1 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03047317
- Acronym / sponsor ID
- 2017-PT041
- Conditions
- Healthy
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 8 Feb 2017 (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 an open label study of MABp1 in six healthy volunteers. Participants will receive a single infusion of MABp1 at the 7.5 mg/kg IV dose. Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks (pre-infusion, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 12 hr, 24 hr, 48 hr, 96 hr, 192 hr, and 336 hr). In addition to pharmacokinetic data, participants will be monitored for the development of treatment emergent adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MABp1 | Experimental | Biological: MABp1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: ≥18
- Adequate bone marrow function as defined as:
- Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
- Adequate hepatic function defined as:
- For WOCBP, a negative pregnancy test at screening. For subjects with reproductive potential, a willingness to utilize contraception during the study and for at least 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and for at least 3 months after study completion.
Key exclusion criteria (18 listed)
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Uncontrolled or significant cardiovascular disease, including:
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- Serious uncontrolled medical disorders, such as uncontrolled diabetes, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the protocol.
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 |
|---|---|---|
| MABp1Single dose of intravenous MABp1 | Biological | MABp1 |
Primary outcome
Peak Plasma Concentration
Time frame: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Time to Peak Plasma Concentration
Time frame: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Half Life
Time frame: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
Area under the plasma concentration versus time curve
Time frame: 2 weeks
Pharmacokinetics--blood levels of MABp1 antibody
1 secondary outcome
Incidence of treatment emergent adverse events
Time frame: 2 weeks
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 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Michael Stecher, MD study director
XBiotech, Inc.
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 MABp1 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 11 inclusion and 18 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 16 Feb 2021. 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?
Peak Plasma Concentration (time frame: 2 weeks). The study lists 4 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 16 Feb 2021.