Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief 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. During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.
Interventions
BIOLOGICALTAK-881
Participants will receive SC infusion of TAK-881.
BIOLOGICALHyQvia
Participants will receive SC infusion of HyQvia.
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.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and Women between 18 and 50 years can participate. 2. Must be a non-smoker, with no use of nicotine or tobacco products. 3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg). 4. Must be medically healthy. 5. Must follow protocol-specified contraception guidance.
Exclusion criteria
1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition. 2. History of alcohol or drug abuse within 2 years before dosing. 3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components. 4. History or presence of thrombotic/thromboembolic events, or venous thrombosis. 5. Pregnant or breastfeeding. 6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements. 7. Recently donated blood or blood products. 8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening. 9. Has taken biologic agents within 12 weeks of screening. 10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening. 11. Has received any vaccine (including live attenuated vaccines and COVID-19 vaccines) during the last 30 days before dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels | Day 1 up to Day 85 | Baseline-uncorrected Cmax based on serum total IgG levels was reported for TAK-881 and HyQvia. |
| Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels | Day 1 up to Day 85 | Baseline-uncorrected Tmax based on serum total IgG levels was reported for TAK-881 and HyQvia. |
| Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels | Day 1 up to Day 29 | Baseline-uncorrected AUC Day1-29 based on serum total IgG levels was reported for TAK-881 and HyQvia. |
| Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels | 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. |
| Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Cmax Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Tmax Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels | 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. |
| Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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). |
| Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions | 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. |
| Number of Participants With Positive Binding Antibodies to rHuPH20 | 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. |
| Number of Participants With Neutralizing Antibodies to rHuPH20 | At Days -1, 29, and 85 | Number of participants with neutralizing antibodies to rHuPH20 were reported. |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Takeda
Participant flow
Recruitment details
This study was conducted at single center in the United States from 24 March 2025 to 8 August 2025.
Pre-assignment details
A total of 30 participants were enrolled and received study treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 9.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
None listed