The main aims of this study are to check for side effects from TAK-881 in healthy adults and to learn how much TAK-881 they can receive without getting side effects from it. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal tolerability and safety. Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up visit will take place 12 weeks after the TAK-881 infusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive subcutaneous infusion of TAK-881 on Day 1.
Clinical Pharmacology of Miami
Hialeah, Florida, United States
Number of Participants With Tolerability Events Related to Infusion of TAK-881 Per Infusion Site
A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced or the infusion was not interrupted or stopped, due to any treatment-emergent adverse event (TEAE) related to TAK-881. Number of participants with tolerability events related to infusion of TAK-881 per infusion sites (1 and 2) were reported.
Time frame: Up to Day 4
Number of Participants With TEAEs
A TEAE was defined as any event emerged or manifested at or after the initiation of treatment with an Investigational product (IP) or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product. Any clinically significant treatment-emergent changes in clinical laboratory measurements and vital signs were recorded as TEAEs. Number of participants with TEAEs were reported.
Time frame: From the start of study drug administration up to Week 13
Number of Participants With Positive Binding Anti-Drug Antibodies (ADA) and Neutralizing Antibodies to rHuPH20
Positive binding ADA was defined as titer greater than or equal to (\>=) 1:160. Neutralizing antibodies were only tested if binding ADA titer was \>= 1:160. Number of participants with positive binding ADA and neutralizing antibodies to rHuPH20 were reported.
Time frame: Baseline up to Week 13
Number of Participants Who Achieved Maximum Tolerable Infusion Rate Per Infusion Site
The maximum tolerable infusion rate achieved referred to the administration of IGSC, 20% at progressively increasing infusion rates and was defined as the highest infusion rate achieved at which the infusion was tolerable (i.e., no stopping, interruption, or infusion rate reduction due to a TAK-881-related TEAE). The maximum tolerable infusion rate for Infusion Site 2 depended on the planned volume according to the stepwise infusion rate escalation regimen. Number of participants who achieved maximum tolerable infusion rate per infusion sites (1 and 2) for each infusion rate (30, 60, 120, 180, and 300 milliliter per hour \[mL/hour\]) were reported.
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Time frame: Day 1 up to Day 4
Total Volume Infused Per Infusion Site for rHuPH20 and IGSC
Total volume infused per infusion sites (1 and 2) for rHuPH20 and IGSC were reported.
Time frame: At Day 1
Time to Deliver the Total Infused Volume Per Infusion Site
Time to deliver (in minutes) the total infused volume was calculated as (stop date/time of IGSC 20% administration) - (start date/time of rHuPH20 administration). Time to deliver the total infused volume per infusion sites (1 and 2) were reported.
Time frame: At Day 1