At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating TAK-881, HyQvia, and 1 other intervention for Healthy Volunteers. Completed, enrolled 30 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.
Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.
Interventions
Participants will receive SC infusion of TAK-881.
Participants will receive SC infusion of HyQvia.
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.
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.