Healthy VolunteersPhase 1NCT06895967
A Study of TAK-881 and HyQvia in Healthy Adults
A Phase 1 study testing TAK-881, HyQvia and SC Investigational Needle Sets in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
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. 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, HyQvia 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 8 Aug 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.
- 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.
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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-881, HyQvia, 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)
Participants will receive SC infusion of TAK-881.
HyQviaBiological
Also called Immune Globulin Subcutaneous (Human), 10% Solution with rHuPH20
Participants will receive SC infusion of HyQvia.
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.
SC Investigational Needle SetsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TAK-881 1.0 g/kg | Experimental | Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1. Receives: Biological: TAK-881; Device: SC Investigational Needle Sets |
| HyQvia 1g/kg | Experimental | Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1. Receives: Biological: HyQvia; Device: SC Investigational Needle Sets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 up to Day 29
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At Days -1, 29, and 85
Number of Participants With Neutralizing Antibodies to rHuPH20
Number of participants with neutralizing antibodies to rHuPH20 were reported.
Measured: At Days -1, 29, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start24 Mar 2025
- Primary completion24 Jul 2025
- Study completion8 Aug 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895967
- Sponsor's protocol ID
- TAK-881-1002
- Status last verified
- May 2026
- First submitted
- 20 Mar 2025
- Last updated
- 11 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults
- ClinicalTrials.gov ID
- NCT06895967
- Acronym / sponsor ID
- TAK-881-1002
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Posted 11 May 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-881 1.0 g/kg | Experimental | Biological: TAK-881, Device: SC Investigational Needle SetsParticipants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1. |
| HyQvia 1g/kg | Experimental | Biological: HyQvia, Device: SC Investigational Needle SetsParticipants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1. |
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.
- 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.
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)Participants will receive SC infusion of TAK-881. | Biological | TAK-881 1.0 g/kg |
| HyQviaAlso: Immune Globulin Subcutaneous (Human), 10% Solution with rHuPH20Participants will receive SC infusion of HyQvia. | Biological | HyQvia 1g/kg |
| 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 | TAK-881 1.0 g/kg |
| SC Investigational Needle SetsThe 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. | Device | HyQvia 1g/kg |
Primary outcome
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.
15 secondary outcomes
Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 29
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 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 Cmax Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
Baseline-corrected Tmax Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
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 Terminal Half-life (t1/2z) Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels
Time frame: Day 1 up to Day 85
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)
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions
Time frame: On Day 1 (day of the first and only infusion)
Number of Participants With Positive Binding Antibodies to rHuPH20
Time frame: At Days -1, 29, and 85
Number of Participants With Neutralizing Antibodies to rHuPH20
Time frame: At Days -1, 29, and 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.Link 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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Screening Protocol
Pain
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, HyQvia 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 11 Jun 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 11 May 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.