clinical trial · NCT06935266
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
Takeda·phase1·completed·n = 64
Healthy VolunteersTAK-881SC Investigational Needle Sets
brief summary
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 \[EOT\]).
started
Apr 22, 2025
primary completion
Sep 22, 2025
completion
Sep 22, 2025
last updated
Nov 3, 2025
official title
A Phase 1, Open-Label, Within-Dose-Level Randomized Trial to Assess the Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous 20% (Human) With Recombinant Human Hyaluronidase (TAK-881) With Ramp-Up and No Ramp-Up Dosing in Healthy Adult Participants
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol