TAK-881 for Healthy Adults
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements to participate in this trial.
What data supports the effectiveness of the drug TAK-881?
Research on a similar drug, the infliximab biosimilar CT-P13, shows it can be effective in treating Takayasu arteritis, a condition involving inflammation of blood vessels. Patients experienced improvements in disease activity and required lower doses of steroids, suggesting potential benefits for similar treatments.12345
What is the purpose of this trial?
The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels.Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
This trial is for healthy adults who can participate in a study lasting about 19 weeks. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAK-881 subcutaneous infusions with varying dosing schedules
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TAK-881
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier