Trials / Completed
CompletedNCT06935266
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
A Phase 1, Open-Label, Within-Dose-Level Randomized Trial to Assess the Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous 20% (Human) With Recombinant Human Hyaluronidase (TAK-881) With Ramp-Up and No Ramp-Up Dosing in Healthy Adult Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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 \[EOT\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TAK-881 | TAK-881 SC injection. |
| DEVICE | SC Investigational Needle Sets | 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. |
Timeline
- Start date
- 2025-04-22
- Primary completion
- 2025-09-22
- Completion
- 2025-09-22
- First posted
- 2025-04-20
- Last updated
- 2025-11-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06935266. Inclusion in this directory is not an endorsement.