Phase 1
Completed N=16
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
Colitis, Ulcerative · Crohn Disease
Source: ClinicalTrials.gov NCT03329209 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Cmax: Maximum Observed Serum Concentration for Vedolizumab — 136.4120 microgram per milliliter (mcg/mL)
Summary
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Serum Concentration for Vedolizumab |
136.4120 | — |
| PRIMARY AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab |
2342.5803 | — |
| PRIMARY AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab |
2377.6463 | — |
| SECONDARY Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA) |
37.5 | — |
| SECONDARY Percentage of Participants With Positive Neutralizing AVA |
37.5 | — |
Eligibility Criteria
Inclusion Criteria
- The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m^2) inclusive at Screening.
Exclusion Criteria
- Has one or more positive response on the progressive multifocal leukoencephalopathy (PML) subjective symptoms checklist at Screening or before dosing on Day 1.
- Has 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).
- For participants who are negative for hepatitis B surface antigen (HBsAg) but are positive for either surface antibodies and/or core antibodies, hepatitis B virus Deoxyribonucleic Acid (DNA) polymerase chain reaction will be performed and any result that meets or exceeds detection sensitivity will be excluded.
- Has poor peripheral venous access.
- Has a QT interval with Fridericia correction method (QTcF) greater than (>) 430 millisecond (ms) (males) or >450 ms (females) or PR outside the range 120 to 220 ms, confirmed with 1 repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1).
Data sourced from ClinicalTrials.gov (NCT03329209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.