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NCT05059977 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-881 in Healthy Adults
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05059977: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT05059977 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 24 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05059977, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL TAK-881
Study Locations (1)
Florida
- Clinical Pharmacology of Miami - Hialeah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2022-04-12 |
| Phase | Phase 1 |
What the finished NCT05059977 record still lists
NCT05059977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which TAK-881 is the first listed.
NCT05059977 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05059977 about?
NCT05059977 is a clinical study titled "A Study of TAK-881 in Healthy Adults". 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 lowe...
What is the current status of trial NCT05059977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-10-12. Estimated completion is 2022-04-12.
What conditions does trial NCT05059977 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05059977?
The interventions under investigation include: TAK-881 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05059977?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05059977 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05059977's enrollment target sits among peer trials
24 204th of 283 higher than 66 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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