Healthy VolunteersPhase 1NCT06935266

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

A Phase 1 study testing TAK-881 and SC Investigational Needle Sets in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-881 and SC Investigational Needle Sets
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2025to 27 Sep 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Tempe, Arizona, 85283

Other trials in United States

About this study

Official 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

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]).

Conditions: Healthy Volunteers
Being tested: TAK-881, SC Investigational Needle Sets
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-881Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)
TAK-881 SC injection.
SC Investigational Needle SetsDevice
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.

Study groups in NCT06935266
Study group	Role	What they receive
Cohort 1, Schedule B, Treatment Arm 1: TAK-881	Experimental	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. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 1, Schedule C, Treatment Arm 2: TAK-881	Experimental	Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 2, Schedule A, Treatment Arm 3: TAK-881	Experimental	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. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 2, Schedule B: Treatment Arm 4: TAK-881	Experimental	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. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 2, Schedule C: Treatment Arm 5: TAK-881	Experimental	Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 3, Schedule A: Treatment Arm 6: TAK-881	Experimental	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. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 3, Schedule B: Treatment Arm 7: TAK-881	Experimental	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. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets
Cohort 3, Schedule C: Treatment Arm 8: TAK-881	Experimental	Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment
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.
Measured: Up to Day 57
Number of Tolerable Infusions by TAK-881 Treatment
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.
Measured: Up to Day 57

Secondary outcomes (5)

Number of Participants With TEAEs
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.
Measured: 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
Clinical laboratory parameters included analysis of serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values was determined at the investigator's discretion.
Measured: From start of study drug administration up to EOT (up to Week 16)
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
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.
Measured: From start of study drug administration up to EOT (up to Week 16)
Number of Participants With Positive Binding Antibodies to rHuPH20
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.
Measured: Up to Week 16
Number of Participants With Neutralizing Antibodies to Anti-rHuPH20
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.
Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202527 Sep 2025

First posted20 Apr 2025
Study start22 Apr 2025
Primary completion27 Sep 2025
Study completion27 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06935266
Sponsor's protocol ID: TAK-881-1003
Status last verified: Jun 2026
First submitted: 11 Apr 2025
Last updated: 17 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT06935266
Acronym / sponsor ID: TAK-881-1003
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 22 Apr 2025 (actual)
Primary completion: 27 Sep 2025 (actual)
Study completion: 27 Sep 2025 (actual)
First posted: 20 Apr 2025 (actual)
Results: Posted 17 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Cohort 1, Schedule B, Treatment Arm 1: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants 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.
Cohort 1, Schedule C, Treatment Arm 2: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
Cohort 2, Schedule A, Treatment Arm 3: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants 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.
Cohort 2, Schedule B: Treatment Arm 4: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants 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.
Cohort 2, Schedule C: Treatment Arm 5: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
Cohort 3, Schedule A: Treatment Arm 6: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants 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.
Cohort 3, Schedule B: Treatment Arm 7: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants 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.
Cohort 3, Schedule C: Treatment Arm 8: TAK-881	Experimental	Biological: TAK-881, Device: SC Investigational Needle SetsParticipants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-881Also: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)TAK-881 SC injection.	Biological	Cohort 1, Schedule B, Treatment Arm 1: TAK-881, Cohort 1, Schedule C, Treatment Arm 2: TAK-881, Cohort 2, Schedule A, Treatment Arm 3: TAK-881, Cohort 2, Schedule B: Treatment Arm 4: TAK-881, Cohort 2, Schedule C: Treatment Arm 5: TAK-881, Cohort 3, Schedule A: Treatment Arm 6: TAK-881, Cohort 3, Schedule B: Treatment Arm 7: TAK-881, Cohort 3, Schedule C: Treatment Arm 8: TAK-881
SC Investigational Needle SetsThe 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	Cohort 1, Schedule B, Treatment Arm 1: TAK-881, Cohort 1, Schedule C, Treatment Arm 2: TAK-881, Cohort 2, Schedule A, Treatment Arm 3: TAK-881, Cohort 2, Schedule B: Treatment Arm 4: TAK-881, Cohort 2, Schedule C: Treatment Arm 5: TAK-881, Cohort 3, Schedule A: Treatment Arm 6: TAK-881, Cohort 3, Schedule B: Treatment Arm 7: TAK-881, Cohort 3, Schedule C: Treatment Arm 8: TAK-881

Primary outcome

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.
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.

5 secondary outcomes

Number of Participants With TEAEs
Time frame: 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)
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)
Number of Participants With Positive Binding Antibodies to rHuPH20
Time frame: Up to Week 16
Number of Participants With Neutralizing Antibodies to Anti-rHuPH20
Time frame: Up to Week 16

Results and safety

Results posted to the registry on 17 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: TAK-881 Ramp-up Schedule B	8	7
Cohort 1: TAK-881 No Ramp-up Schedule C	8	8
Cohort 2: TAK-881 Ramp-up Schedule A	8	6
Cohort 2: TAK-881 Ramp-up Schedule B	8	8
Cohort 2: TAK-881 No Ramp-up Schedule C	8	8
Cohort 3: TAK-881 Ramp-up Schedule A	8	7
Cohort 3: TAK-881 Ramp-up Schedule B	8	7
Cohort 3: TAK-881 No Ramp-up Schedule C	8	4

Primary outcome: Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment

Time frame: Up to Day 57. Count of participants. Unit: Participants

Measure	Cohort 1: TAK-881 Ramp-up Schedule B n = 8	Cohort 1: TAK-881 No Ramp-up Schedule C n = 8	Cohort 2: TAK-881 Ramp-up Schedule A n = 8	Cohort 2: TAK-881 Ramp-up Schedule B n = 8	Cohort 2: TAK-881 No Ramp-up Schedule C n = 8	Cohort 3: TAK-881 Ramp-up Schedule A n = 8	Cohort 3: TAK-881 Ramp-up Schedule B n = 8	Cohort 3: TAK-881 No Ramp-up Schedule C n = 8
Value	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)	8 (63 to 100)

Population analysed: The SAS included all participants who received any amount of TAK-881.

Primary outcome: Number of Tolerable Infusions by TAK-881 Treatment

Time frame: Up to Day 57. Number. Unit: number of infusions

Measure	Cohort 1: TAK-881 Ramp-up Schedule B n = 8	Cohort 1: TAK-881 No Ramp-up Schedule C n = 8	Cohort 2: TAK-881 Ramp-up Schedule A n = 8	Cohort 2: TAK-881 Ramp-up Schedule B n = 8	Cohort 2: TAK-881 No Ramp-up Schedule C n = 8	Cohort 3: TAK-881 Ramp-up Schedule A n = 8	Cohort 3: TAK-881 Ramp-up Schedule B n = 8	Cohort 3: TAK-881 No Ramp-up Schedule C n = 8
Value	31 (89 to 100)	24 (86 to 100)	35 (90 to 100)	32 (89 to 100)	24 (86 to 100)	46 (92 to 100)	42 (92 to 100)	31 (89 to 100)

Population analysed: The SAS included all participants who received any amount of TAK-881. Here, 'overall number of units analyzed' refers to the total number of infusions administered for the TAK-881 treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to EOT (up to Week 16). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: TAK-881 Ramp-up Schedule B	1 of 8 (12.5%)	8 of 8 (100%)	0 of 8
Cohort 1: TAK-881 No Ramp-up Schedule C	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 2: TAK-881 Ramp-up Schedule A	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 2: TAK-881 Ramp-up Schedule B	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 2: TAK-881 No Ramp-up Schedule C	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 3: TAK-881 Ramp-up Schedule A	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 3: TAK-881 Ramp-up Schedule B	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Cohort 3: TAK-881 No Ramp-up Schedule C	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-881 and SC Investigational Needle Sets in people with Healthy Volunteers, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment (time frame: Up to Day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935266.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.