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NCT05098080 · ClinicalTrials.gov registry record · Phase 1
Hutrukin to Analyze Safety and PK in Healthy Volunteers
A Phase 1 study, sponsored by XBiotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05098080: Completed Phase 1 study, sponsored by XBiotech.
NCT05098080 is a Phase 1 study that has completed, run by XBiotech. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05098080, a Phase 1 study, has completed, sponsored by XBiotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg).
Primary Outcome
Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v5.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Hutrukin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-04-10 |
| Est. Completion | 2024-04-05 |
| Phase | Phase 1 |
What the finished NCT05098080 record still lists
NCT05098080 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05098080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05098080 about?
NCT05098080 is a clinical study titled "Hutrukin to Analyze Safety and PK in Healthy Volunteers". The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg).
What is the current status of trial NCT05098080?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-04-10. Estimated completion is 2024-04-05.
What interventions are being tested in trial NCT05098080?
The interventions under investigation include: Placebo (BIOLOGICAL), Hutrukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05098080?
This trial is sponsored by XBiotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05098080's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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