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Completed

NCT Number: NCT06895967

A Study 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

TAK-881

Biological

Participants will receive SC infusion of TAK-881.

Other names: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)

HyQvia

Biological

Participants will receive SC infusion of HyQvia.

Other names: Immune Globulin Subcutaneous (Human), 10% Solution with rHuPH20

SC Investigational Needle Sets

Device

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.

Primary outcomes

  1. 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

    Time frame: Day 1 up to Day 29

    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.

Secondary outcomes

  1. Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia.

  2. Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia.

  3. Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 29

    Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia.

  4. Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  5. Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  6. Baseline-corrected Cmax Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  7. Baseline-corrected Tmax Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  8. Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels

    Time frame: From Day 1 up to Day 85

    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.

  9. Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  10. Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  11. Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels

    Time frame: Day 1 up to Day 85

    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.

  12. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From start of study drug up to end of trial (up to Day 85)

    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).

  13. Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions

    Time frame: On Day 1 (day of the first and only infusion)

    The number of participants with infusion withdrawals, interruptions, and infusion rate reductions due to TAK-881 or HyQvia related TEAEs were reported.

  14. Number of Participants With Positive Binding Antibodies to rHuPH20

    Time frame: At Days -1, 29, and 85

    Number of participants with positive binding antibodies to recombinant human hyaluronidase (rHuPH20) with titer greater than or equal to (>=) 1:160 were reported.

  15. Number of Participants With Neutralizing Antibodies to rHuPH20

    Time frame: At Days -1, 29, and 85

    Number of participants with neutralizing antibodies to rHuPH20 were reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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