| Eligibility |
Inclusion Criteria:
1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.
2. The participant signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures including
requesting that a participant fast for any laboratory evaluations.
3. Is a cytochrome P-450 (CYP)2C9, CYP2C19, and CYP2D6 extensive metabolizer, based on
genotyping of pharmacogenomic (PGx) deoxyribonucleic acid (DNA) analysis.
4. Is a male or female aged 18 to 55 years, inclusive, at Screening.
5. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) of 18.0 to 30
kilogram per square meter (kg/m^2), inclusive, at Screening and Check-in (Day -1).
6. The healthy control participants in Part 1 of this study will be matched at Day-1 with
the UC or CD participants in Group 1 or 3 (whichever enrolls faster) on the basis of
age (+/-10 years), gender and weight (+/-30 [percent] %).
7. Participants in Part 2 and Group 1 will be matched on Day-1 on the basis of the
inflammatory bowel disease (IBD) diagnosis (UC or CD), age (+/-10 years), gender and
weight (+/-30%).
For Part 1 Participants:
8. 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.
9. All female participants who are of childbearing potential and who are sexually active,
agree to routinely use adequate contraception from signing of informed consent
throughout the duration of the study. NOTE: Female participants NOT of childbearing
potential are defined as those who have been surgically sterilized (hysterectomy,
bilateral oophorectomy, tubal ligation [at least 2 years post-operation]) or who are
postmenopausal (example, defined as at least 1 year since last regular menses with an
follicle stimulated hormone [FSH] greater than [>] 40 international units per liter
[IU/L] or at least 5 years since last regular menses, confirmed before any study
medication is implemented).
For Part 1 Only Participants with UC or CD
10. Has a diagnosis of UC or CD established at least 6 months prior to enrollment by
clinical and endoscopic evidence and corroborated by a histopathology report.
11. Prior to entering the study, participants with UC must have had an endoscopy during
screening to confirm active disease, with Mayo score of 6 to 12 and an endoscopic
subscore greater than or equal to (>=)2. Participants with CD must have a Crohn's
Disease Activity Index (CDAI) score of 220 to 450 to confirm moderate to severe
disease on entry (that is, Day-1).
12. Participant may be receiving a therapeutic dose of the following drugs for treatment
of their underlying disease:
- Oral or topical 5-aminosalicylic acid (5-ASA) compounds provided that the dose
has been stable for the 2 weeks immediately prior to enrollment.
- Probiotics (example, Culturelle, Saccharomyces boulardii) provided that the dose
has been stable for the 2 weeks immediately prior to enrollment.
- Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of
chronic diarrhea.
- Azathioprine or 6-mercaptopurine, provided that the dose has been stable for the
8 weeks immediately prior to enrollment.
- Methotrexate provided that the dose has been stable for the 8 weeks immediately
prior to randomization.
- Oral corticosteroid therapy (prednisone at a stable dose less than or equal to
[<=] 30 milligram per day [mg/day], or equivalent steroid) provided that the dose
has been stable for the 4 weeks immediately prior to enrollment, if
corticosteroids have been initiated, or for the 2 weeks immediately prior to the
enrollment, if corticosteroids are being tapered.
13. C-reactive protein (CRP) >=5 milligram per liter (mg/L) during screening period in
participants with CD.
For Part 1 Healthy Participants Only:
14. The participant, in opinion of the investigator, is in healthy condition as determined
by a prestudy physical examination, medical history, vital signs, electrocardiogram
(ECG), and the results of blood biochemistry, hematology, serology, and urinalysis
tests.
For Part 2 Participants with Active UC and CD:
15. 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 57 days after last dose.
16. All female participants who are of childbearing potential and who are sexually active
with a nonsterilized male partner, agree to routinely use adequate contraception from
Screening until 57 days after receiving the last dose of study medication. NOTE:
Female participants NOT of childbearing potential are defined as those who have been
surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation [at least
2 years post-operation]) or who are postmenopausal (example, defined as at least 1
year since last regular menses with an FSH >40 IU/L or at least 5 years since last
regular menses, confirmed before any study medication is implemented.
17. Has a diagnosis of UC or CD established at least 6 months prior to enrollment by
clinical and endoscopic evidence and corroborated by a histopathology report.
18. Is on established vedolizumab intravenous (IV) for treatment of UC or CD and is in
clinical remission as assessed within 7 days of dosing defined for UC; A complete Mayo
score of <=2 points and no individual subscore >1 point. For CD; CDAI of <=150 points.
19. Participant may be receiving a therapeutic dose of the following drugs for treatment
of their underlying disease:
- Oral or topical ASA compounds provided that the dose has been stable for the 2
weeks immediately prior to enrollment.
- Probiotics (example, Culturelle, S. boulardii) provided that the dose has been
stable for the 2 weeks immediately prior to enrollment.
- Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of
chronic diarrhea.
- Azathioprine or 6-mercaptopurine, provided that the dose has been stable for the
8 weeks immediately prior to enrollment.
- Methotrexate provided that the dose has been stable for the 8 weeks immediately
prior to randomization.
- Oral corticosteroid therapy (prednisone at a stable dose <30 mg/day, or
equivalent steroid) provided that the dose has been stable for the 4 weeks
immediately prior to enrollment if corticosteroids have been initiated or for the
2 weeks immediately prior to the enrollment if corticosteroids are being tapered.
Exclusion Criteria:
For both Part 1 and Part 2:
1. Has a known hypersensitivity to any of the drugs or components in the Injection (Inje)
Cocktail.
2. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in the conduct of this study (example,
spouse, parent, child, sibling) or may consent under duress.
3. Within 30 days prior to enrollment, participants with UC or CD have received any
treatment of underlying disease other than those specifically listed in the protocol
for the Treatment of UC or CD.
4. If female, the participant is pregnant or lactating or intending to become pregnant
before, during, or within 57 days after participating in this study; or intending to
donate ova during such time period.
5. If male, the participant intends to donate sperm during the course of this study or
for 57 days thereafter.
6. Has received rituximab or natalizumab treatment or other integrin inhibitors.
7. Has taken any excluded medication, supplements, or food products listed in the
protocol.
8. Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
9. Has had extensive colonic resection, subtotal or total colectomy.
10. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
11. Has evidence of or has had treatment for Clostridium difficile infection within 60
days or other intestinal pathogen within 30 days prior to enrollment.
12. Has a history or evidence of adenomatous colonic polyps that have not been removed.
13. Has a history or evidence of colonic mucosal dysplasia.
14. Has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
15. Has any identified congenital or acquired immunodeficiency (example, common variable
immunodeficiency, human immunodeficiency virus [HIV] infection, organ
transplantation).
16. Has received any live vaccinations within 30 days prior to study drug administration
except for the influenza vaccine.
17. Has clinically significant infection (example, pneumonia, pyelonephritis) within 30
days prior to enrollment.
18. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, genitourinary, hematological, coagulation, immunological,
endocrine/metabolic, or other medical disorder that, in the opinion of the
investigator, would confound the study results or compromise participant safety.
19. Has had any surgical procedure requiring general anesthesia within 30 days prior to
enrollment or is planning to undergo major surgery during the study period.
20. Has any history of malignancy, except for the following: (a) adequately treated
nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
adequately treated and that has not recurred for at least 1 year prior to enrollment;
and (c) history of cervical carcinoma in situ that has been adequately treated and
that has not recurred for at least 3 years prior to enrollment. Participants with
remote history of malignancy (example, >10 years since completion of curative therapy
without recurrence) will be considered based on the nature of the malignancy and the
therapy received and must be discussed with the sponsor on a case-by-case basis prior
to enrollment.
21. Has a current or recent history (within 1 year prior to enrollment) of alcohol
dependence or illicit drug use.
22. Has active psychiatric problems that, in the investigator's opinion, may interfere
with compliance with the study procedures.
23. Is unable to attend all the study visits or comply with study procedures.
For Part 1 Participants With UC or CD:
24. Has received any investigational or approved biologic or biosimilar agent in the last
6 months prior to Screening.
25. Participant currently requires or is anticipated to require surgical intervention for
UC or CD during the study.
For Part 1 Healthy Participants Only:
26. Has laboratory abnormalities considered to be clinically significant by the
investigator during the Screening Period, for example the following:
- Hemoglobin level less than (<) 10 gram per decilitre (g/dL).
- White blood cell (WBC) count <3*10^9 per liter (/L).
- Lymphocyte count <0.5*10^9/L.
- Platelet count <100*10^9/L or >1200*10^9/L.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit
of normal (ULN).
- Alkaline phosphatase >ULN.
- Serum creatinine >1.5*ULN.
For Part 1 Participants with UC or CD and Part 2 Participants:
27. Has any of the following laboratory abnormalities considered to be clinically
significant by the investigator during the Screening Period:
- Hemoglobin level <8 g/dL.
- WBC count <3*10^9/L.
- Lymphocyte count <0.5 x 10^9/L.
- Platelet count <100*10^9/L or >1200*10^9/L.
- ALT or AST >3*ULN.
- Alkaline phosphatase >3*ULN.
- Serum creatinine >2*ULN.
For Part 2 only:
28. Has received any investigational or approved biologic or biosimilar agents other than
vedolizumab in the last 6 months prior to Screening.
29. The subject has active or latent tuberculosis (TB), this may involve documentation of
the participant's TB status prior to commencing vedolizumab with the participant's own
treating physician.
30. Has a history of any major neurological disorders, including stroke, multiple
sclerosis, brain tumor, or neurodegenerative disease.
31. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist at screening and prior to dosing on Day 1.
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