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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
64
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.
Celerion
Tempe, Arizona, United States
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.
Time frame: 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.
Time frame: Up to Day 57
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.
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
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Clinical laboratory parameters included analysis of serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values was determined at the investigator's discretion.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 16