Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration
Condition: Healthy
Intervention: Vedolizumab SC; Vedolizumab IV
Intervention description: Vedolizumab injection, for subcutaneous use (vedolizumab SC); Vedolizumab injection, for intravenous use (vedolizumab IV)
Intervention MeSH terms: Vedolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the absolute bioavailability and pharmacokinetics of
      vedolizumab following a single injection of vedolizumab subcutaneously at 3 varying doses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant, or when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any study procedures.

          3. Is a healthy male or female adult of non-Japanese decent 18 to 60 years of age
             inclusive or of Japanese descent (born to Japanese parents and grandparents and has
             lived outside Japan for less than 5 years), 20 to 60 years of age inclusive, at the
             time of informed consent.

          4. Weighs at least 45 kg (99 lb) and have a body mass index (BMI) between 18.0 and 30.0
             kg/m^2 for non-Japanese participants or 18.0 and 28.0 kg/m^2 for Japanese
             participants, inclusive at Screening.

          5. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for a minimum of 18 weeks after last
             dose.

          6. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use acceptable methods of contraception from
             signing of informed consent throughout the duration of the study and for a minimum of
             18 weeks after last dose.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to dosing of study
             medication or history of treatment with another monoclonal antibody within 6 months to
             dosing of study medication.

          2. Has received vedolizumab in a previous clinical study or as a therapeutic agent.

          3. Is an immediate family member, study site employee, or in a dependant relationship
             with a study site employee who is involved in the conduct of this study (eg, spouse,
             parent, child, sibling) or may consent under duress.

          4. Has uncontrolled, clinically significant (CS) neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease,
             or psychiatric disorder, or other abnormality, that may impact the ability of the
             participant or potentially confound the study results.

          5. Has a known hypersensitivity to any component of the formulation of vedolizumab SC or
             vedolizumab IV.

          6. Has one or more positive responses on the progressive multifocal leukoencephalitis
             (PML) subjective symptom checklist at screening or before dosing on Day 1.

          7. Has a positive result for drugs of abuse or alcohol at Screening or Check- in (Day
             -1).

          8. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
             from alcohol for 48 hrs prior to Day -1 throughout confinement and for 48 hrs prior to
             each clinic visit and drugs throughout the study.

          9. Is pregnant or lactating or intends to become pregnant before, during, or within 18
             weeks after the last dose in this study; or intends to donate ova during such time
             period.

         10. If male, the participant intends to donate sperm during the course of this study or
             for 18 weeks after the last dose in this study.

         11. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic
             disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy,
             asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding
             in the participant's medical history, physical examination, or safety laboratory tests
             giving reasonable suspicion of a disease that would contraindicate taking vedolizumab,
             or a similar drug in the same class, or that might interfere with the conduct of this
             study. This includes, but is not limited to, peptic ulcer disease, seizure disorders,
             and cardiac arrhythmias.

         12. Had a surgical procedure requiring general anesthesia within 30 days before the
             initial Screening Visit, or is planning to undergo a surgery that requires general
             anesthesia during the study period through Final Visit Day 127.

         13. Has a history of cancer, except basal cell carcinoma that has been in remission for at
             least 5 years prior to Day 1.

         14. Participant is unable to attend all study days or comply with protocol requirements.