Vedolizumab SC
DrugVedolizumab SC liquid.
Other names: MLN0002, ENTYVIO, KYNTELES
NCT Number: NCT03961308
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Celerion, Tempe, Arizona, United States
The drug being tested in this study is called vedolizumab SC. The study will compare the PK of a vedolizumab SC in a PFS to an investigational device.
This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 102 participants per group (a total of 204 participants), including 34 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
All participants will receive a single dose of study drug on Day 1.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:
Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
Vedolizumab SC liquid.
Other names: MLN0002, ENTYVIO, KYNTELES
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to Day 127) post-dose
Takeda
Industry
A Phase 1, Open-Label, Randomized, Parallel Group Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Vedolizumab Administered in Prefilled Syringe Versus Prefilled Syringe in Autoinjector in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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