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OpenTrials
Completed

NCT Number: NCT06935266

A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.

During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous [SC] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels.

Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment [EOT]).

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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 for at least 3 months prior to the first dosing.
  • Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m^2).
  • 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 coronavirus disease 2019 [COVID-19] vaccines) during the last 30 days before dosing.

Treatment and study plan

TAK-881

Biological

TAK-881 SC injection.

Other names: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20), 20% Solution with Recombinant Human Hyaluronidase (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. Number of Participants With Tolerable Infusions of TAK-881

    Time frame: From start of the study drug administration up to Day 57

    A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881.

  2. Number of Tolerable Infusions

    Time frame: From start of the study drug administration up to Day 57

    A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881.

Secondary outcomes

  1. Number of Participants With TEAEs

    Time frame: From start of the study drug administration up to Week 16

    TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

  2. Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

    Time frame: Up to Week 16

    Laboratory parameters will include serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.

  3. Number of Participants With Clinically Significant Changes in Vital Sign Values

    Time frame: Up to Week 16

    Vital signs will include measurement of heart rate/ pulse rate, systolic, diastolic blood pressure, body temperature and respiratory rate. Clinical significance of vital signs will be determined at the investigator's discretion.

  4. Number of Participants With Positive Binding Antibodies (Titer Greater Than or Equal to [>=] 1:160)

    Time frame: Up to Week 16

  5. Number of Participants With Neutralizing Antibodies to rHuPH20

    Time frame: Up to Week 16

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 1, Open-Label, Within-Dose-Level Randomized Trial to Assess the Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous 20% (Human) With Recombinant Human Hyaluronidase (TAK-881) With Ramp-Up and No Ramp-Up Dosing in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Nov 3, 2025

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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