A Pharmacokinetic Study of MABp1 in Healthy Volunteers
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MABp1
|
Biological: MABp1
Single dose of intravenous MABp1
|
Outcome Measures
Primary Outcome Measures
- Peak Plasma Concentration [2 weeks]
Pharmacokinetics--blood levels of MABp1 antibody
- Time to Peak Plasma Concentration [2 weeks]
Pharmacokinetics--blood levels of MABp1 antibody
- Half Life [2 weeks]
Pharmacokinetics--blood levels of MABp1 antibody
- Area under the plasma concentration versus time curve [2 weeks]
Pharmacokinetics--blood levels of MABp1 antibody
Secondary Outcome Measures
- Incidence of treatment emergent adverse events [2 weeks]
The occurrence and incidence of treatment emergent adverse events will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: ≥18
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Adequate bone marrow function as defined as:
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absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
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platelet count > 150,000/mm3
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hemoglobin of ≥ 10 g/dL
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Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
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Adequate hepatic function defined as:
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total bilirubin ≤ 1.5 times lab ULN.
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alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
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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.
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Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.
Exclusion Criteria:
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Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
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Uncontrolled or significant cardiovascular disease, including:
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A myocardial infarction within the past 6 months.
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Uncontrolled angina within the past 3 months.
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Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Classes II or higher.
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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.
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Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
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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.
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History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
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Infectious disease:
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CRP >30 mg/L, or infection requiring treatment with antibiotics within 3 weeks prior to Screening,
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Positive HIV, RPR, Hepatitis C antibody, or IGRA
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Immunodeficiency by history.
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Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
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Major surgery within 28 days prior to Day 0.
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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.
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History of progressive multifocal leukoencephalopathy or other demyelinating disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | XBiotech Investigative Site | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Michael Stecher, MD, XBiotech, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-PT041