Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06935266
PHASE1

A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

Sponsor: Takeda

View on ClinicalTrials.gov

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 \[EOT\]).

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-04-22

Completion Date

2025-09-27

Last Updated

2026-08-17

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

TAK-881

TAK-881 SC injection.

DEVICE

SC Investigational Needle Sets

The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Locations (1)

Celerion

Tempe, Arizona, United States