A Study of TAK-881 and HyQvia in Healthy Adults
NCT06895967 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-11
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
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-24
- Primary Completion
- 2025-07-24
- Completion
- 2025-07-24
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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