Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief 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 higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).
Interventions
BIOLOGICALTAK-881
TAK-881 SC injection.
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 for at least 3 months prior to the first dosing. 3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2). 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 coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Tolerated All Initiated Infusions by TAK-881 Treatment | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs | 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. |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | 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. |
| Number of Participants With Clinically Significant Changes in Vital Sign Parameters | 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. |
| Number of Participants With Positive Binding Antibodies to rHuPH20 | 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. |
| Number of Participants With Neutralizing Antibodies to Anti-rHuPH20 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Takeda
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 22 April 2025 to 27 September 2025.
Pre-assignment details
A total of 64 healthy adult participants were enrolled in the study. Cohort 1 (16 participants) evaluated a ramp-up dosing schedule (Schedule B) and no ramp-up dosing schedule (Schedule C). Cohort 2 and 3 (Each 24 participants) evaluated 2 ramp-up dosing schedules (Schedules A and B) and a no ramp-up dosing schedule (Schedule C).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 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 | 54 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 | 8 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
None listed