A Pharmacokinetic Study of MABp1 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: MABp1

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • XBiotech Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: ≥18

2. 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
3. Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.

4. Adequate hepatic function defined as:

   • total bilirubin ≤ 1.5 times lab ULN.
   • alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
5. 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.
6. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

1. Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).

2. 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).
3. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
4. Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
5. 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.
6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.

7. 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
8. Immunodeficiency by history.
9. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
10. Major surgery within 28 days prior to Day 0.
11. 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.
12. History of progressive multifocal leukoencephalopathy or other demyelinating disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MABp1	Biological: MABp1; Single dose of intravenous MABp1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration	Pharmacokinetics--blood levels of MABp1 antibody	2 weeks
Time to Peak Plasma Concentration	Pharmacokinetics--blood levels of MABp1 antibody	2 weeks
Half Life	Pharmacokinetics--blood levels of MABp1 antibody	2 weeks
Area under the plasma concentration versus time curve	Pharmacokinetics--blood levels of MABp1 antibody	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events	The occurrence and incidence of treatment emergent adverse events will be recorded.	2 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Michael Stecher, MD, XBiotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): March 8, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pharmacokinetics
• Other Study ID Numbers: 2017-PT041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No