A Pharmacokinetic Study of MABp1 in Healthy Volunteers

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Janssen

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Biological: MABp1

Study type

Interventional

Funder types

Industry

Identifiers

NCT03047317
2017-PT041

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

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.

Exclusion criteria

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).
  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

MABp1
Experimental group
Treatment:
Biological: MABp1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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