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

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.

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.

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.

Clinical laboratory parameters included analysis of serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values was determined at the investigator's discretion.

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.

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.

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.