NCT05059977

A Study of TAK-881 in Healthy Adults

A Phase 1, Single-Dose, Single-Center, Open-Label, Three-Arm Study to Assess the Tolerability and Safety of Immune Globulin Subcutaneous (Human), 20% Solution With Recombinant Human Hyaluronidase (TAK-881) at Various Infusion Rates in Healthy Adult Subject

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal tolerability and safety. Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up visit will take place 12 weeks after the TAK-881 infusion.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	TAK-881	Participants will receive subcutaneous infusion of TAK-881 on Day 1.

Timeline

• Start date: 2021-10-12
• Primary completion: 2022-04-12
• Completion: 2022-04-12
• First posted: 2021-09-28
• Last updated: 2024-01-12
• Results posted: 2024-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study