A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
June 26, 2026 updated by: Takeda
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
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]).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1, Schedule B, Treatment Arm 1: TAK-881
Participants will receive TAK-881, subcutaneous (SC) injection, 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, 0.6 g/kg on Days 22 and 50 in ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 1, Schedule C, Treatment Arm 2: TAK-881
Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 2, Schedule A, Treatment Arm 3: TAK-881
Participants will receive TAK-881, SC injection, 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50 in ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 2, Schedule B: Treatment Arm 4: TAK-881
Participants will receive TAK-881, SC injection, 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50 in ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 2, Schedule C: Treatment Arm 5: TAK-881
Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 3, Schedule A: Treatment Arm 6: TAK-881
Participants will receive TAK-881, SC injection, 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50 in ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 3, Schedule B: Treatment Arm 7: TAK-881
Participants will receive TAK-881, SC injection, 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50 in ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
|
Experimental: Cohort 3, Schedule C: Treatment Arm 8: TAK-881
Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.
|
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.
TAK-881 SC injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment
Time Frame: Up to Day 57
|
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881.
An infusion was considered to be tolerable if the participant had tolerated both the recombinant human hyaluronidase (rHuPH20) and immune globulin subcutaneous (IGSC) 20 percent (%) components of TAK-881.
The number of participants who tolerated all initiated infusions by TAK-881 treatment were reported in this outcome measure.
|
Up to Day 57
|
|
Number of Tolerable Infusions by TAK-881 Treatment
Time Frame: Up to Day 57
|
A tolerable infusion was considered to have occurred if an infusion was completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881.
The number of tolerable infusions by TAK-881 treatment were reported in this outcome measure.
|
Up to Day 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With TEAEs
Time Frame: From start of study drug administration up to end of trial (EOT) (up to Week 16)
|
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the investigational product (IP), whether or not the occurrence was considered related to the IP.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the IP.
A TEAE was defined as any AE that was not present prior to the initiation of the treatments or any pre-existing AE that worsened in either intensity or frequency after receiving the first dose of trial intervention in this trial through 98 (±7) days after the last dose of trial intervention.
Number of participants with TEAEs were reported in this outcome measure.
|
From start of study drug administration up to end of trial (EOT) (up to Week 16)
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Time Frame: From start of study drug administration up to EOT (up to Week 16)
|
Clinical laboratory parameters included analysis of serum chemistry, hematology, coagulation and urinalysis.
Clinical significance of laboratory values was determined at the investigator's discretion.
|
From start of study drug administration up to EOT (up to Week 16)
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Time Frame: From start of study drug administration up to EOT (up to Week 16)
|
Vital signs parameters included measurement of pulse rate, blood pressure, body temperature and respiratory rate.
Clinical significance of vital signs was determined at the investigator's discretion.
|
From start of study drug administration up to EOT (up to Week 16)
|
|
Number of Participants With Positive Binding Antibodies to rHuPH20
Time Frame: Up to Week 16
|
The binding antibodies were considered as "positive" if corresponding titer was >= 1:160.
Number of participants with positive binding antibodies to rHuPH20 with titer >=1:160 were reported in this outcome measure.
|
Up to Week 16
|
|
Number of Participants With Neutralizing Antibodies to Anti-rHuPH20
Time Frame: Up to Week 16
|
All participants were monitored for the formation of anti-rHuPH20 antibodies using validated anti-rHuPH20 antibody detection assay (also known as the screening and confirmatory binding assay).
Post-dose samples with antibody titers >=1 :160 were analyzed for the presence of neutralizing-ADA using a validated assay based on neutralization of rHuPH20 activity.
Number of participants with neutralizing antibodies to anti-rHuPH20 were reported in this outcome measure.
|
Up to Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Takeda
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2025
Primary Completion (Actual)
September 27, 2025
Study Completion (Actual)
September 27, 2025
Study Registration Dates
First Submitted
April 11, 2025
First Submitted That Met QC Criteria
April 11, 2025
First Posted (Actual)
April 20, 2025
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
June 26, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-881-1003
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
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