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NCT06935266 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT06935266: Completed Phase 1 study, sponsored by Takeda.
NCT06935266 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06935266, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study 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 \[EOT\]).
Primary Outcome
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 infusio
Interventions
- BIOLOGICAL TAK-881
- DEVICE SC Investigational Needle Sets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2025-04-22 |
| Est. Completion | 2025-09-22 |
| Phase | Phase 1 |
What the finished NCT06935266 record still lists
NCT06935266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which TAK-881 is the first listed.
NCT06935266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06935266 about?
NCT06935266 is a clinical study titled "A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults". 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 mu...
What is the current status of trial NCT06935266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2025-04-22. Estimated completion is 2025-09-22.
What interventions are being tested in trial NCT06935266?
The interventions under investigation include: TAK-881 (BIOLOGICAL), SC Investigational Needle Sets (DEVICE).
Who is sponsoring clinical trial NCT06935266?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06935266's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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