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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: TAK-881; Device: SC Investigational Needle Sets; Device: SC Investigational Needle Sets; Biological: HyQvia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men and Women between 18 and 50 years can participate.
2. Must be a non-smoker, with no use of nicotine or tobacco products.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
4. Must be medically healthy.
5. Must follow protocol-specified contraception guidance.

Exclusion Criteria:

1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
2. History of alcohol or drug abuse within 2 years before dosing.
3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
5. Pregnant or breastfeeding.
6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
7. Recently donated blood or blood products.
8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
9. Has taken biologic agents within 12 weeks of screening.
10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
11. Has received any vaccine (including live attenuated vaccines and COVID-19 vaccines) during the last 30 days before dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAK-881 1.0 g/kg; Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.	Biological: TAK-881; Participants will receive SC infusion of TAK-881.; Other Names: Immune Globulin Subcutaneous (Human); 20% Solution with Recombinant Human Hyaluronidase (rHuPH20); 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.
Experimental: HyQvia 1g/kg; Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.	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.; Biological: HyQvia; Participants will receive SC infusion of HyQvia.; Other Names: Immune Globulin Subcutaneous (Human); 10% Solution with rHuPH20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels	Baseline-corrected AUC Day 1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels	Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia.	Day 1 up to Day 85
Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels	Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia.	Day 1 up to Day 85
Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels	Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia.	Day 1 up to Day 29
Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels	Baseline-corrected AUCinf based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels	Baseline-corrected AUClast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected Cmax Based on Serum Total IgG Levels	Baseline-corrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected Tmax Based on Serum Total IgG Levels	Baseline-corrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels	Baseline-corrected Tlast based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	From Day 1 up to Day 85
Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels	Baseline-corrected t1/2z based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels	Baseline-corrected CL/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels	Baseline-corrected Vz/F based on serum total IgG levels was reported for TAK-881 and HyQvia. Baseline-corrected concentration is equal to serum total IgG post-dose concentration minus the baseline concentration.	Day 1 up to Day 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as any AE that was starting or worsening at the time of or after dosing of investigational product (IP).	From start of study drug up to end of trial (up to Day 85)
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions	The number of participants with infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881 or HyQvia related TEAEs were reported.	On Day 1 (day of the first and only infusion)
Number of Participants With Positive Binding Antibodies to rHuPH20	Number of participants with positive binding antibodies to recombinant human hyaluronidase (rHuPH20) with titer greater than or equal to (>=) 1:160 were reported.	At Days -1, 29, and 85
Number of Participants With Neutralizing Antibodies to rHuPH20	Number of participants with neutralizing antibodies to rHuPH20 were reported.	At Days -1, 29, and 85

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Actual): July 24, 2025
• Study Completion (Actual): July 24, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Pharmaceutical Preparations; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; gamma-Globulins; Solutions
• Other Study ID Numbers: TAK-881-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes