NCT06895967

A Study of TAK-881 and HyQvia in Healthy Adults

A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults. Study participants will receive a single dose of TAK-881 or HyQvia on Day 1. During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	TAK-881	Participants will receive SC infusion of TAK-881.
BIOLOGICAL	HyQvia	Participants will receive SC infusion of HyQvia.
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.
DEVICE	SC Investigational Needle Sets	The single-use only SC needle set will be used to administer HyQvia to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-07-24
• Completion: 2025-07-24
• First posted: 2025-03-26
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study