A Study of TAK-881 in Healthy Adults

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.

Timeline

Start

2021-10-12

Primary completion

2022-04-12

Completion

2022-04-12

Publications

• Nagy A, Duff K, Bauer A, Okonneh F, Rondon JC, Yel L, Li Z. A Phase 1 Open-Label Study to Assess the Tolerability, Safety, and Immunogenicity of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 20% in Healthy Adults. J Clin Immunol. 2023 Dec 22;44(1):28. doi: 10.1007/s10875-023-01632-2.

Drugs

Indications

No indication recorded.