NCT03329209 is a Phase 1 clinical trial of Vedolizumab in Colitis, Ulcerative, sponsored by Takeda.

Who is sponsoring NCT03329209?

NCT03329209 is sponsored by Takeda.

What drugs are being tested in NCT03329209?

Interventions in NCT03329209: Vedolizumab.

What condition does NCT03329209 study?

NCT03329209 studies Colitis, Ulcerative, Crohn Disease.

Is NCT03329209 still recruiting?

NCT03329209 is currently completed. Last updated 6 September 2019.

Are results published for NCT03329209?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-06 · How we verify

NCT03329209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

Completed Phase 1 Results posted Last updated 6 September 2019

What this trial tests

Phase 1 trial testing Vedolizumab in Colitis, Ulcerative in 16 participants. Completed in 5 September 2018.

Timeline

5 March 2018

Primary endpoint
26 July 2018

5 September 2018

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	16
Start date	5 March 2018
Primary completion	26 July 2018
Estimated completion	5 September 2018
Sites	1 location across China

Drugs / interventions tested

Vedolizumab (vedolizumab) — full drug profile →

Conditions studied

Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
Crohn Disease — all drugs for Crohn Disease →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 45, any sex, with Colitis, Ulcerative or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cmax: Maximum Observed Serum Concentration for Vedolizumab Primary · Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Group	Value	95% CI
Vedolizumab 300 mg	136.4120	± 15.90597

AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab Primary · Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Group	Value	95% CI
Vedolizumab 300 mg	2342.5803	± 294.75822

AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab Primary · Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Group	Value	95% CI
Vedolizumab 300 mg	2377.6463	± 296.46345

Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA) Secondary · Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Group	Value	95% CI
Vedolizumab 300 mg	37.5

Percentage of Participants With Positive Neutralizing AVA Secondary · Day 1 pre-dose and at multiple time points (up to Day 127) post-dose

Group	Value	95% CI
Vedolizumab 300 mg	37.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events (TEAE) are adverse events that started after the infusion of study drug and no more than Day 127. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vedolizumab 300 mg

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (4 terms — click to expand)

Reaction	System	Vedolizumab 300 mg
Upper respiratory tract infection	Infections and infestations	—
Leukocyturia	Renal and urinary disorders	—
Blood creatine phosphokinase increased	Investigations	—
Hepatic enzyme increased	Investigations	—

Data from ClinicalTrials.gov NCT03329209 adverse events section.

Sponsor's own description

The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Vedolizumab

Trials testing the same drug.

NCT06646016 — EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis · Phase 2 · withdrawn
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
NCT06227910 — A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease · Phase 3 · recruiting
NCT06443502 — A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pou · Phase 3 · recruiting
NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio · Phase 3 · terminated

Other recruiting trials for Colitis, Ulcerative

Currently open trials in the same condition.

NCT07302360 — A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03329209 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 6 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03329209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing